International Breast Cancer Study Group (IBCSG)

The Breast International Group

doi:10.1017/S1470903106009229

International Breast Cancer Study Group (IBCSG)

Published online by Cambridge University Press: 04 December 2006

Article contents

Abstract
IBCSG – Contact Details
IBCSG – Study Details

Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by International Breast Cancer Study Group (IBCSG). Clinical trials include:

CMF with or without prednisone for pre/perimenopausal patients with breast cancer and 1–3 positive nodes. Ludwig/IBCSG Trial I
CMF + prednisone combined with or without oophorectomy for pre/perimenopausal patients with breast cancer and 4 or more positive nodes. Ludwig/IBCSG Trial II
Adjuvant therapy for postmenopausal elderly patients (older than 65): observation versus prednisone tamoxifen. Ludwig/IBCSG Trial III
Adjuvant therapy for postmenopausal, 65 years or younger, node-positive breast cancer patients: observation versus prednisone + tamoxifen versus CMF + prednisone + tamoxifen. Ludwig/IBCSG Trial IV
Adjuvant perioperative chemotherapy. Ludwig/IBCSG Trial V
Adjuvant therapy in node-positive pre/perimenopausal breast cancer patients: CMF 3 versus 6 with or without reintroduction of chemotherapy. IBCSG Trial VI
Adjuvant chemotherapy in node-positive postmenopausal breast cancer patients: endocrine versus chemo-endocrine versus chemo-endocrine with delayed chemotherapy. IBCSG Trial VII
Adjuvant therapy in pre- and perimenopausal patients with node-negative breast cancer. Observation versus LH-RH analogue versus CMF versus CMF + LN-RH analogue. IBCSG Trial VIII
Adjuvant therapy in postmenopausal patients with node-negative breast cancer. Tamoxifen versus CMF followed by tamoxifen. IBCSG Trial IX
Surgical therapy with or without axillary node clearance for breast cancer in elderly patients who receive adjuvant therapy with tamoxifen. IBCSG Trial 10–93
Adjuvant therapy for premenopausal patients with node-positive breast cancer who are suitable for endocrine therapy alone. IBCSG Trial 11–93
Adjuvant therapy for post/perimenopausal patients with node-positive breast cancer who have estrogen-receptor-positive tumors. IBCSG Trial 12–93
Adjuvant therapy for premenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 13–93
Adjuvant therapy for post perimenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 14–93
High dose EC × 3 supported by PBSC versus EC/AC × 4 followed by CMF as adjuvant treatment for high-risk operable Stage II and Stage III breast cancer in premenopausal and young postmenopausal (<65 years) patients. IBCSG Trial 15–95
Adjuvant therapy for postmenopausal patients with operable breast cancer who have estrogen-receptor or progesterone-receptor-positive tumors. Tamoxifen versus letrozole versus tamoxifen followed by letrozole versus letrozole followed by tamoxifen. BIG 1–98 / IBCSG Trial 18–98
Maintenance chemotherapy in hormone non-responsive breast cancer: low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer. IBCSG Trial 22–00
A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node-negative breast cancer and micrometastases in the sentinel node. IBCSG Trial 23–01
Suppression of Ovarian Function Trial (SOFT). A Phase III trial evaluating the role of ovarian function suppression (OFS) and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer. Tamoxifen versus OFS + tamoxifen versus OFS + exemestane. BIG 2–02/IBCSG Trial 24–02
Tamoxifen and Exemestane Trial (TEXT). A Phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer. Ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane. BIG 3–02/IBCSG Trial 25–02
Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE) A Phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer who receive endocrine therapy.
Chemotherapy + OFS + tamoxifen/exemestane versus OFS + tamoxifen/ exemestane. BIG 4–02/IBCSG Trial 26–02
Chemotherapy for radically resected loco-regional relapse. BIG 1-02/IBCSG Trial 27–02/NSABP Protocol B-37
Chemotherapy adjuvant study for women at advanced Age (CASA) Phase III trial evaluating the role of adjuvant pegylated liposomal doxorubicin (PLD) for women (age 66 years or older) with endocrine non-responsive breast cancer who are not suitable for being offered a “standard chemotherapy regimen”. BIG 1–05/IBCSG Trial 32–05

Type: Other
Information: Breast Cancer Online , Volume 9 , Supplement S1: AN OVERVIEW OF RECENT AND ONGOING CLINICAL TRIALS FOR BREAST CANCER 4th EDITION , December 2006 , pp. 226 - 280 , e64

DOI: https://doi.org/10.1017/S1470903106009229 [Opens in a new window]
Copyright: © 2006 Cambridge University Press

IBCSG – Contact Details

Country

Europe, America, Australia, Africa, Asia

Foundation Council Chair

B. Thürlimann, Senologie-Zentrum Ostschweiz, Kantonsspital, CH-9007 ST GALLEN, SWITZERLAND. Tel: +41 71 494 20 65 Fax: +41 71 494 63 68 Email: [email protected]

Scientific Committee Chair

A. Goldhirsch, IOSI, Oncology Institute of Southern Switzerland, c/o Ospedale Italiano, Via Capelli, CH-6962 VIGANELLO-LUGANO, SWITZERLAND and Department of Medicine, European Institute of Oncology, I-20141 MILANO, ITALY. Tel: +41 91 811 79 23 Fax: +41 91 811 79 25 Email: [email protected]

A. Coates, 40 Cook RD, Centennial Park, NSW 2021, AUSTRALIA. Tel: +61 2 9331 3521 Fax: N/A. Email: [email protected]

Chief Executive Officer

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Coordinating Center

A. Hiltbrunner, Executive Director, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

R. Studer, Head Trial Coordination, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9392 Email: [email protected]

Statistical and Data Management Center Director

R.D. Gelber, IBCSG Statistical Center, Dana-Farber Cancer Institute, 44 Binney St., BOSTON, MA 02115 USA. Tel: +1 617 632 3603 Fax: +1 617 632 2444 Email: [email protected]

L. Blacher, Director of Data Management, Frontier Science & Technology, Research Foundation, 4033 Maple Road, AMHERST, NY 14226 USA. Tel: +1 716 834 0900 Fax: +1 716 836 6097 Email: [email protected]

Quality of Life Office Responsible Person

K. Ribi, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9229 Email: [email protected]

Pathology Center Responsible Person

G. Viale, European Institute of Oncology (EIO), Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 5748 9420 Fax: +39 02 5748 9417 Email: [email protected]

B.A. Gusterson, University of Glasgow, Western Infirmary, Royal Cancer Hospital, The Haddow Hospital, 15 Cotswold Road, GLASGOW G11 6NT, UNITED KINGDOM. Tel: +44 141 211 2233 Fax: +44 141 337 2494 Email: [email protected]

Website

www.ibcsg.org

IBCSG – Study Details

Title

CMF with or without prednisone for pre/perimenopausal patients with breast cancer and 1–3 positive nodes. Ludwig/IBCSG Trial I

CMF + prednisone combined with or without oophorectomy for pre/perimenopausal patients with breast cancer and 4 or more positive nodes. Ludwig/IBCSG Trial II

Adjuvant therapy for postmenopausal elderly patients (older than 65): observation versus prednisone + tamoxifen. Ludwig/IBCSG Trial III

Adjuvant therapy for postmenopausal, 65 years or younger, node-positive breast cancer patients: observation versus prednisone + tamoxifen versus CMF + prednisone + tamoxifen. Ludwig/IBCSG Trial IV

Coordinator(s)

A. Goldhirsch, IOSI, Oncology Institute of Southern Switzerland, c/o Ospedale Italiano, Via Capelli, CH-6962 VIGANELLO-LUGANO, SWITZERLAND and Department of Medicine, European Institute of Oncology, I-20141 Milano, ITALY. Tel: +41 91 811 79 23 Fax: +41 91 811 79 25 Email: [email protected]

Summary

Closed in September 1981 (opened in 1978)
Final accrual for Trials I–IV: 1713 patients

Objectives

To determine whether we can increase the tumor-free interval or increase survival by combining hormone therapy and cytotoxic chemotherapy when comparing:

CMF plus prednisone (CMFp) versus CMF alone for relatively good prognosis pre- and perimenopausal (1–3 positive nodes) patients.
CMFp plus oophorectomy versus CMFp for poor prognosis (>4 positive nodes) pre- and perimenopausal patients.
CMFp plus Tam, versus Tam and prednisone, versus no adjuvant therapy for postmenopausal patients (N+) up to the age of 65.
Tam plus prednisone versus no adjuvant therapy for postmenopausal (N+) women 66 years and over.

Scheme

Update

See publications.

Related publications

Aebi S, Gelber S, Castiglione-Gertsch M, et al. for the International Breast Cancer Study Group (IBCSG). Is chemotherapy alone adequate for young women with oestrogen-receptor-positive breast cancer? Lancet 2000; 355: 1869–1874 (Trials I–VI).

Anbazhagan R, Gelber RD, Bettelheim R, Goldhirsch A, Gusterson BA. Association of c-erbB-2 expression and S-phase fraction in the prognosis of node positive breast cancer. Ann Oncol 1991; 2: 47–53 (Trials I–IV).

Berclaz G, Li S, Price KN, et al. on behalf of the IBCSG. Body mass index as a prognostic feature in operable breast cancer: the International Breast Cancer Study Group experience. Ann Oncol 2004; 15: 875–884 (Trials I–VII).

Castiglione M, Gelber RD, Goldhirsch A. Adjuvant systemic therapy for breast cancer in the elderly: competing causes of mortality. J Clin Oncol 1990; 8: 519–526 (Trial IV).

Castiglione-Gertsch M, Johnsen C, Goldhirsch A, et al. for the International Breast Cancer Study Group. The International (Ludwig) Breast Cancer Study Group Trials I–IV: 15 years follow-up. Ann Oncol 1994; 5: 717–724 (Trials I–IV).

Castiglione-Gertsch M, Tattersall M, Hacking A, et al. for the IBCSG. Retreating recurrent breast cancer with the same CMF-containing regimen used as adjuvant therapy. Eur J Cancer 1997; 33: 2321–2325 (Trials I–V).

Cole BF, Gelber RD, Gelber S, Coates AS, Goldhirsch A. Polychemotherapy for early breast cancer: an overview of the randomised clinical trials with quality-adjusted survival analysis. The Lancet 2001; 358: 277–286 (Trial III).

Colleoni M, Bonetti M, Coates AS, et al. for the International Breast Cancer Study Group. Early start of adjuvant chemotherapy improves treatment outcome for premenopausal breast cancer patients with tumors not expressing estrogen receptor. J Clin Oncol 2000; 18: 584–590 (Trials I–V).

Colleoni M, Li S, Gelber RD, et al. for the International Breast Cancer Study Group. Relation between chemotherapy dose, oestrogen receptor expression, and body-mass index. Lancet 2005; 366: 1108–1110 (Trials I, II, V, VI).

Colleoni M, O'Neill A, Goldhirsch A, et al. for the International (Ludwig) Breast Cancer Study Group. Identifying breast cancer patients at high risk for bone metastases. J Clin Oncol 2000; 18: 3925–3935 (Trials I–VII).

Colleoni M, Price K, Castiglione-Gertsch M, Gelber R, Coates A, Goldhirsch A, for the International Breast Cancer Study Group (IBCSG). Mortality during adjuvant treatment of early breast cancer with cyclophosphamide, methotrexate, fluorouracil (CMF regimen). Lancet 1999; 354: 130–131 (Trials I–VII).

Colleoni M, Price K, Goldhirsch A, et al. for the IBCSG. Dose–response effect of adjuvant cyclophosphamide, methotrexate, fluorouracil (CMF) in node-positive breast cancer. Eur J Cancer 1998; 34: 1693–1700 (Trials I–V).

Colleoni M, Zahrieh D, Gelber RD, et al. Site of primary tumor has a prognostic role in operable breast cancer: the International Breast Cancer Study Group experience. J Clin Oncol 2005; 23: 1390–1400 (Trials I–VII, IX).

Crivellari D, Price K, Gelber RD, et al. for the IBCSG. Adjuvant endocrine therapy compared with no systemic therapy for elderly women with early breast cancer: 21-year results of International Breast Cancer Study Group Trial IV. J Clin Oncol 2003; 21: 4517–23.

Crivellari D, Price KN, Hagen M, et al. for the International (Ludwig) Breast Cancer Study Group (IBCSG): Routine tests during follow-up of patients after primary treatment for operable breast cancer. Ann Oncol 1995; 6: 769–776 (Trials I–V).

Davis BW, Gelber RD, Goldhirsch A, et al. Prognostic significance of peritumoral vessel invasion in clinical trials of adjuvant therapy for breast cancer with axillary lymph node metastasis. Hum Pathol 1985; 16: 1212–1218 (Trials I–IV).

Davis BW, Gelber RD, Goldhirsch A, et al. for the Ludwig Breast Cancer Study Group: Prognostic significance of tumor grade in clinical trials of adjuvant therapy for breast cancer with axillary lymph node metastasis. Cancer 1986; 58: 2662–2670 (Trials I–IV).

Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 1998; 352: 930–942 (Trial III).

Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effect of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687–1717 (Trials II, III, VI, VII, IX, 11–93).

Gelber RD and Goldhirsch A, for the Ludwig Breast Cancer Study Group: A new endpoint for the assessment of adjuvant therapy in postmenopausal women with operable breast cancer. J Clin Oncol 1986; 4: 1772–1779 (Trial III).

Gianni L, Panzini I, Li S, et al. for the IBCSG. Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group Trials. Cancer 2006; 106: 505–513 (Trials III, IV, VII, IX, 11–93, 12–93, 14–93).

Goldhirsch A, for the Ludwig Breast Cancer Study Group: Adjuvant treatment in operable breast cancer. J Steroid Biochem 1985; 23: 1155–1160 (Trials I–IV).

Goldhirsch A and Gelber RD, for the Ludwig Breast Cancer Study Group: Adjuvant treatment for early breast cancer: the Ludwig Breast Cancer Studies. J Natl Cancer Inst Monogr 1986; 1: 55–70 (Trials I–IV).

Goldhirsch A, Gelber RD, Castiglione M, for the Ludwig Breast Cancer Study Group: Relapse of breast cancer after adjuvant treatment in premenopausal and perimenopausal women: patterns and prognoses. J Clin Oncol 1988; 6: 89–97 (Trials I–II).

Goldhirsch A, Gelber RD, Castiglione M, et al. for the International Breast Cancer Study Group. The best available adjuvant treatments are within the framework of clinical trials. Isr J Med Sci 1995; 31: 145–154 (Trials I–V).

Goldhirsch A, Gelber R, Price K, et al. for the International Breast Cancer Study Group: Effect of systemic adjuvant treatment on first sites of breast cancer relapse. Lancet 1994; 343: 377–381 (Trials I–V).

Goldhirsch A, Gelber RD, Simes RJ, Glasziou P, Coates AS, for the Ludwig Breast Cancer Study Group. Costs and benefits of adjuvant therapy in breast cancer: A quality-adjusted survival analysis. Classic Papers and Current Comments 1996; 1: 152–160 (Trial III).

Goldhirsch A, Gelber RD, Yothers G, et al. Adjuvant therapy for very young women with breast cancer: need for tailored treatments. J Natl Cancer Inst Monogr 2001; 30: 44–51 (Trials I–VI).

Hedley DW, Rugg CA, Gelber RD, for the Ludwig Breast Cancer Study Group: Association of DNA index and S-phase fraction with prognosis of N+ early breast cancer. Cancer Res 1987; 47: 4729–4735 (Trials I–IV).

International Breast Cancer Study Group: Late effects of adjuvant oophorectomy and chemotherapy upon premenopausal breast cancer patients. Ann Oncol 1990; 1: 30–35 (Trial II).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials 1–14).

Ludwig Breast Cancer Study Group: Randomised trial of chemoendocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet 1984; i: 1256–1260 (Trial III).

Ludwig Breast Cancer Study Group: A randomized trial of adjuvant combination chemotherapy with or without prednisone in premenopausal breast cancer patients with metastases in one to three axillary lymph nodes. Cancer Res 1985; 45: 4454–4459 (Trial I).

Ludwig Breast Cancer Study Group: Chemotherapy with or without oophorectomy in high-risk premenopausal patients with operable breast cancer. J Clin Oncol 1985; 3: 1059–1067 (Trial II).

Marini G, Murray S, Goldhirsch A, et al. The effect of adjuvant prednisone combined with CMF on patterns of relapse and occurrence of second malignancies in patients with breast cancer. Ann Oncol 1996; 7: 245–250 (Trial I).

Nathan B, Gusterson B, Jadayel D, et al. Expression of BCL-2 in primary breast cancer and its correlation with tumour phenotype. Ann Oncol 1994; 5: 409–414 (Trials I–IV).

Pedrazzini A, Gelber RD, Isley M, Castiglione M and Goldhirsch A, for the Ludwig Breast Cancer Study Group: First repeated bone scan in the observation of patients with operable breast cancer. J Clin Oncol 1986; 4: 389–394 (Trials I–IV).

Rudenstam C-M, for the Ludwig Breast Cancer Study Group: The Ludwig breast cancer studies in postmenopausal patients with axillary node metastasis. Rev Endocrine-Related Cancer 1985; 17: 25–32 (Trials III–IV).

Spataro V, Price K, Goldhirsch A, et al. for the International Breast Cancer Study Group (formerly Ludwig Group): Sequential estrogen receptor determinations from primary breast cancer and at relapse: prognostic and therapeutic relevance. Ann Oncol 1992; 3: 733–740 (Trials I–V).

Wallgren A, Bonetti M, Gelber RD, et al. for the IBCSG. Risk factors for locoregional recurrence among breast cancer patients: Results from International Breast Cancer Study Group Trials I Through VII. J Clin Oncol 2003; 21: 1205–1213 (Trials I–VII).

Topics

Axillary lymph node dissection
Hormonal therapy, Node-positive breast cancer
Ovarian suppression (Trial II)
Pre- and perimenopausal patients (Trials I & II)
Postmenopausal patients (Trials III & IV)
Tamoxifen (Trials III & IV)

Keywords

Breast cancer, total mastectomy, prednisone, chemotherapy, endocrine therapy

***************************************************

Title

Adjuvant perioperative chemotherapy. Ludwig/IBCSG Trial V

Coordinator(s)

A. Goldhirsch, IOSI, Oncology Institute of Southern Switzerland, c/o Ospedale Italiano, Via Capelli, CH-6962 VIGANELLO-LUGANO, SWITZERLAND, and, Department of Medicine, European Institute of Oncology, I-20141 MILANO, ITALY. Tel: +41 91 811 79 23 Fax: +41 91 811 79 25 Email: [email protected]

Summary

Closed in December 1985 (opened in 1981)
Final accrual: 2628 patients

Objectives

To assess the value of a combination of perioperative chemotherapy and conventionally timed adjuvant therapy as compared with perioperative therapy alone and conventionally timed therapy alone in N+ patients.
To assess the value of perioperative chemotherapy in patients with proven breast cancer who are classified as N− post-surgically.
To investigate the biological and toxic effects of perioperative therapy.
To identify clinical, biological, and immuno-morphological risk factors in N− patients.
To investigate the relationship of ER status to response to perioperative and/or conventionally timed adjuvant therapy in N+ and N− patients.

Scheme

Update

See publications.

Related Publicatons

Colleoni M, Gelber S, Coates A, et al. for the IBCSG. Influence of endocrine-related factors on response to perioperative chemotherapy for patients with node-negative breast cancer. J Clin Oncol 2001; 19: 4141–4149 (Trial V).

Cote RJ, Peterson HF, Chaiwun B, et al. The role of the immuno-histochemical detection of lymph node metastases in the management of breast cancer. Lancet 1999; 354: 896–900 (Trial V).

Gelber S, Coates AS, Goldhirsch A, et al. for the International Breast Cancer Study Group (IBCSG). Effect of pregnancy on overall survival following the diagnosis of early stage breast cancer. J Clin Oncol 2001; 19: 1671–1675 (Trials V and VI).

Gelber RD, Goldhirsch A, Cavalli F. Quality-of-life adjusted evaluation of adjuvant therapies for operable breast cancer. Ann Int Med 1991; 114: 621–628 (Trial V).

Goldhirsch A, Castiglione M, Gelber RD for the International Breast Cancer Study Group: A single perioperative adjuvant chemotherapy course for node-negative breast cancer: five-year results of trial V. J Natl Cancer Inst Monogr 1992; 11: 89–96 (Trial V).

Goldhirsch A, Gelber RD, Castiglione M, et al. for the International Breast Cancer Study Group. The best available adjuvant treatments are within the framework of clinical trials. Isr J Med Sci 1995; 31: 145–154 (Trials I–V).

Goldhirsch A, Gelber RD, Yothers G, et al. Adjuvant therapy for very young women with breast cancer: need for tailored treatments. J Natl Cancer Inst Monogr 2001; 30: 44–51 (Trials I–VI).

Gusterson BA, Gelber RD, Goldhirsch A, et al. for the International Breast Cancer Study Group: Prognostic importance of c-erbB-2 expression in breast cancer. J Clin Oncol 1992; 10: 1049–1056 (Trial V).

Gusterson BA, Gelber RD, Goldhirsch A, et al. for the International Breast Cancer Study Group: Prognostic importance of c-erbB-2 expression in breast cancer. Classic Papers Curr Comm 1996; 1: 32–40 (Trial V).

Gusterson BA, Gelber RD, Goldhirsch A, et al. for the International Breast Cancer Study Group: Prognostic importance of c-erbB-2 expression in breast cancer. J Clin Oncol/Classic Papers and Current Comments 2001; 5: 908–916 (Trial V).

Gusterson BA, Taylor CW, Price KN, Gelber RD, Säve-Söderberght J, Anbazhagan R, et al. Prognostic value of Helix Pomatia in breast cancer. Br J Cancer 1993; 68: 146–150 (Trial V).

International (Ludwig) Breast Cancer Study Group. Prognostic importance of occult axillary lymph node metastases from breast cancers. Lancet 1990; 335: 1565–1568 (Trial V).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials I–14).

Ludwig Breast Cancer Study Group. Combination adjuvant chemotherapy for node-positive breast cancer. Inadequacy of a single perioperative cycle. New Engl J Med 1988; 319: 677–683 (Trial V).

Ludwig Breast Cancer Study Group. On the safety of perioperative adjuvant chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil in breast cancer. Eur J Cancer Clin Oncol 1988; 24: 1305–1308 (Trial V).

Ludwig Breast Cancer Study Group. Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer. New Engl J Med 1989; 320: 491–496 (Trial V).

Neville AM, Bettelheim R, Gelber R, et al. for the International Breast Cancer Study Group: Factors predicting treatment responsiveness and prognosis in node-negative breast cancer. J Clin Oncol 1992; 10: 696–705 (Trial V).

Pestalozzi BC, Peterson HF, Gelber RD, et al. The prognostic importance of thymidylate synthase expression in early breast cancer. J Clin Oncol 1997; 15: 1923–1931 (Trial V).

Pinder SE, Murray S, Ellis IO, et al. The importance of histological grade in invasive breast carcinoma and response to chemotherapy. Cancer 1998; 83: 1529–1539 (Trial V).

Spataro VJ, Litman H, Viale G, et al. Decreased immunoreactivity for p27 protein in patients with early-stage breast carcinoma is correlated with HER-2/neu overexpression and with benefit from one course of perioperative chemotherapy in patients with negative lymph node status: results from International Breast Cancer Study Group Trial V. Cancer 2003; 97: 1591–1600 (Trial V).

Trihia H, Murray S, Price K, et al. Ki-67 expression in breast carcinoma: its association with grading systems, clinical parameters, and other prognostic factors – A surrogate marker? Cancer 2003; 97: 1321–1331 (Trial V).

Wallgren A, Bonetti M, Gelber RD, et al. for the IBCSG. Risk factors for locoregional recurrence among breast cancer patients: results from International Breast Cancer Study Group Trials I through VII. J Clin Oncol 2003; 21: 1205–1213 (Trials I–VII).

Topics

Node-negative breast cancer
Node-positive breast cancer
Perioperative chemotherapy
Tamoxifen

Keywords

Histologically or cytologically confirmed operable breast cancer, total mastectomy, CMF, tamoxifen, perioperative chemotherapy

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Title

Adjuvant therapy in node-positive pre/perimenopausal breast cancer patients: CMF 3 versus 6 with or without reintroduction of chemotherapy. IBCSG Trial VI

Coordinator(s)

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in April 1993 (opened in July, 1986)
Final accrual: 1505 patients

Objectives

To determine whether delayed administration of adjuvant chemotherapy (reintroduction) given after a treatment-free interval improves the outcome.
To determine whether 3 cycles of adjuvant chemotherapy (given initially) are as effective as 6 cycles.

Scheme

Update

See publications.

Related Publications

Bernhard J, Hürny C, Coates A, Gelber R. Applying Quality of Life Principles in International Cancer Clinical Trials. Int Clin Trials 1996; 72: 693–705 (Trials VI–VII).

Bernhard J, Hürny C, Coates AS, et al. for the International Breast Cancer Study Group (IBCSG). Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach. Ann Oncol 1997; 8: 825–835 (Trials VI–VII).

Bernhard J, Hürny Ch, Coates AS, et al. for the IBCSG. Factors affecting baseline quality of life in two international adjuvant breast cancer trials. Br J Cancer 1998; 78: 686–693 (Trials VI–VII).

Bernhard J, Peterson HF, Coates AS, et al. for the International Breast Cancer Study Group. Quality of life assessment in international breast cancer study group (IBCSG) trials: practical issues and factors associated with missing data. Stat Med 1998; 17: 587–601 (Trials VI–VII).

Bernhard J, Sullivan M, Hürny C, Coates AS, Rudenstam C-M. Clinical relevance of single item quality of life indicators in cancer clinical trials. Br J Cancer 2001; 84: 1156–1165 (Trials VI–VII).

Coates AS, Hürny C, Peterson HF, et al. for the IBCSG. Quality of life scores predict outcome in metastatic but not in early breast cancer. J Clin Oncol 2000; 18: 3768–3774 (Trials VI–VII).

Colleoni M, Litman HJ, Castiglione-Gertsch M, et al. for the International Breast Cancer Study Group and the German Breast Cancer Study Group. Duration of adjuvant chemotherapy for breast cancer: A joint analysis of two randomised trials investigating 3 versus 6 courses of CMF (cyclophosphamide, methotrexate, and 5-fluorouracil). Br J Cancer 2002; 86: 1705–1714 (Trial VI).

Goldhirsch A, Gelber R, Castiglione M, et al. and other members of the IBCSG. Menstrual cycle and timing of breast surgery in premenopausal node-positive breast cancer: Results of the International Breast Cancer Study Group (IBCSG) Trial VI. Ann Oncol 1997; 8: 751–756 (Trial VI).

Goldhirsch A, Gelber RD, Yothers G, et al. Adjuvant therapy for very young women with breast cancer: need for tailored treatments. J Natl Cancer Inst Monogr 2001; 30: 44–51 (Trials I–VI).

Gruber G, Bonetti M, Nasi ML, et al. for the IBCSG. Prognostic value of extracapsular tumor spread for locoregional control in premenopausal patients with node-positive breast cancer treated with classical cyclophosphamide, methotrexate, and fluorouracil: Long-term observations from International Breast Cancer Study Group Trial VI. J Clin Oncol 2005; 23: 7089–7097 (Trial VI).

Hürny C, Bernhard J, Coates A, et al. for the International Breast Cancer Study Group: Timing of baseline quality of life assessment in an international adjuvant breast cancer trial: its effect on patient estimation. Ann Oncol 1994; 5: 65–74 (Trials VI–VII).

Hürny C, Bernhard J, Coates A, et al. for the International Breast Cancer Study Group (IBCSG). Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial. Med Care 1996; 34: 234–248 (Trials VI–VII).

Hürny C, Bernhard J, Coates AS, et al. for the International Breast Cancer Study Group (IBCSG): Impact of adjuvant therapy on quality of life in women with node-positive operable breast cancer. Lancet 1996; 347: 1279–1284 (Trials VI–VII).

Hürny Ch, Bernhard J, Gelber RD, et al. for the International Breast Cancer Study Group: Quality of life measures for patients receiving adjuvant therapy for breast cancer: an international trial. Eur J Cancer 1992; 28: 118–124 (Trials VI–VII).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials I–14).

Pagani O, O'Neill A, Castiglione M, et al. Prognostic impact of amenorrhoea after adjuvant chemotherapy in premenopausal breast cancer patients with axillary node involvement: results of the International Breast Cancer Study Group (IBCSG) Trial VI. Eur J Cancer 1998; 34: 632–640 (Trial VI).

The International Breast Cancer Study Group. Duration and reintroduction of adjuvant chemotherapy for node-positive premenopausal breast cancer patients. J Clin Oncol 1996; 14: 1885–1894 (Trial VI).

Wallgren A, Bernier J, Gelber RD, et al. for the International Breast Cancer Study Group: Timing of radiotherapy and chemotherapy following breast-conserving surgery for patients with node-positive breast cancer. Int J Rad Onc Biol Phys 1996; 35: 649–659 (Trials VI–VII).

Topics

Node-positive breast cancer
Premenopausal patients

Keywords

Breast cancer, chemotherapy, CMF, pre/perimenopausal patients, quality of life

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Title

Adjuvant chemotherapy in node-positive postmenopausal breast cancer patients: endocrine versus chemo-endocrine versus chemo-endocrine with delayed chemotherapy.

IBCSG Trial VII

Coordinator(s)

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN. SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in April 1993 (opened in July 1986)
Final accrual: 1266 patients

Objectives

To determine whether chemo-endocrine therapy improves outcome compared to tamoxifen alone.
To determine whether delayed single courses of adjuvant chemotherapy added to tamoxifen alone improve outcome.

Scheme

Update

See publications.

Related Publications

Bernhard J, Hürny C, Coates A, Gelber R. Applying quality of life principles in international cancer clinical trials. Int Clin Trials 1996; 72: 693–705 (Trials VI–VII).

Bonetti M, Cole BF, Gelber RD. A method-of-moments estimation procedure for categorical quality-of-life data with nonignorable missingness. JASA1999;94: 1025–1034 (Trial VII).

Bonetti M, Gelber RD. A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data. Stat in Med 2000; 19: 2595–2609 (Trial VII).

Colleoni M, Li S, Gelber RD, et al. for the International Breast Cancer Study Group. Timing of CMF chemotherapy in combination with tamoxifen in postmenopausal women with breast cancer: role of endocrine responsiveness of the tumor. Ann Oncol 2005; 16: 716–725 (Trials VII and IX).

Crivellari D, Bonetti M, Castiglione-Gertsch M, et al. for the IBCSG. Burdens and benefits of adjuvant CMF and tamoxifen for elderly patients with breast cancer: the IBCSG Trial VII. J Clin Oncol 2000; 18: 1412–1422 (Trial VII).

Coates AS, Hürny C, Peterson HF, et al. for the IBCSG. Quality of life scores predict outcome in metastatic but not in early breast cancer. J Clin Oncol 2000; 18: 3768–3774 (Trials VI–VII).

Cole BF, Bonetti M, Zaslavsky AM, Gelber RD. A multistate Markov chain model for longitudinal, categorical quality-of-life data subject to non-ignorable missingness. Stat Med 2005; 24: 2317–2334 (Trial VII).

Gelber RD, Bonetti M, Castiglione-Gertsch M, Coates AS, Goldhirsch A for the IBCSG. Tailoring adjuvant treatments for the individual breast cancer patient. The Breast 2003; 12: 558–568 (Trials VII and IX).

Gianni L, Panzini I, Li S, et al. for the IBCSG. Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group Trials. Cancer 2006; 106:505–513 (Trials III, IV, VII, IX, 11–93, 12–93, 14–93).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials I–14).

Regan MM, Gelber RD. Predicting response to systemic treatments: learning from the past to plan for the future. The Breast 2005; 14: 582–593 (Trials VII and IX).

The International Breast Cancer Study Group. Effectiveness of adjuvant chemotherapy in combination with tamoxifen for node-positive postmenopausal breast cancer patients. J Clin Oncol 1997; 15: 1385–1393 (Trial VII).

Topics

Node-positive breast cancer
Postmenopausal patients
Tamoxifen

Keywords

Node-positive breast cancer, chemotherapy, CMF, tamoxifen, quality of life

***************************************************

Title

Adjuvant therapy in pre- and perimenopausal patients with node-negative breast cancer. Observation versus LH–RH analogue versus CMF versus CMF + LN–RH analogue.

IBCSG Trial VIII

Coordinator(s)

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in October 1999 (opened in March 1990)

Final accrual: 1111 patients

Objectives

To determine whether the use of an LH-RH analogue following 6 months of cyclophosphamide, methotrexate, fluorouracil (CMF) chemotherapy reduces relapse and prolongs survival as compared to the use of either a 2-year administration of an LH–RH analogue alone or the use of 6 months of CMF alone.
To investigate the patients' perceptions on well-being and coping during adjuvant treatment, after therapy but before relapse, and after relapse.

Scheme

Update

See publications.

Related Publications

Aebi S and Castiglione-Gertsch M. Adjuvant endocrine therapy for the very young patients. The Breast 2003; 12: 509–515 (Trial VIII).

Castiglione-Gertsch M, Gelber RD, Coates AS, O'Neill A, Goldhirsch A, for the IBCSG. Systemic adjuvant treatment for premenopausal node-negative breast cancer. Eur J Canc2000; 36: 549–550 (Trial VIII).

International Breast Cancer Study Group. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst 2003; 95: 1833–1846 (Trial VIII).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials 1–14).

Topics

Node-negative breast cancer
Premenopausal patients

Keywords

Pre- and perimenopausal patients, oral CMF, LH–RH analogue, quality of life

***************************************************

Title

Adjuvant therapy in postmenopausal patients with node-negative breast cancer. Tamoxifen versus CMF followed by tamoxifen.

IBCSG Trial IX

Coordinator(s)

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in August 1999 (opened in October 1988)
Final accrual: 1715 patients

Objectives

To evaluate if the addition of 3 cycles of initial chemotherapy to adjuvant tamoxifen improves outcome.
To evaluate quality of life.

Scheme

Update

See publications.

Related Publications

Bernhard J, Zahrieh D, Coates AS, et al. for the IBCSG. Quantifying trade-offs: quality of life and quality-adjusted survival in a randomised trial of chemotherapy in postmenopausal patients with lymph node-negative breast cancer. Br J Cancer 2004; 91: 1893–1901 (Trial IX).

Bonetti M, Gelber RD. Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics 2004; 5 (3): 465–481 (Trial IX).

Castiglione-Gertsch M for the International Breast Cancer Study Group. Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node-negative breast cancer: a randomized trial of the International Breast Cancer Study Group. Am J Oncol Rev 2002; 1: 286–289 (Trial IX).

Gelber RD, Bonetti M, Castiglione-Gertsch M, Coates AS, Goldhirsch A for the IBSCG. Tailoring adjuvant treatments for the individual breast cancer patient. The Breast 2003; 12: 558–568 (Trials VII and IX).

International Breast Cancer Study Group. Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node negative breast cancer: a randomized trial. J Natl Cancer Inst 2002; 94: 1054–1065 (Trial IX).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials 1–14).

Regan MM, Gelber RD. Predicting response to systemic treatments: learning from the past to plan for the future. The Breast 2005; 14: 582–593 (Trials VII and IX).

Topics

Hormonal therapy
Node-negative breast cancer
Postmenopausal patients
Tamoxifen

Keywords

Combination CMF-tamoxifen, quality of life

***************************************************

Title

Surgical therapy with or without axillary node clearance for breast cancer in elderly patients who receive adjuvant therapy with tamoxifen.

IBCSG Trial 10–93

Coordinator(s)

D. Crivellari, Centro di Riferimento Oncologico Aviano, Via Pedemontana Occ. 12, I-33081 AVIANO, ITALY. Tel: +39 0434 659 190 Fax: +39 0434 652 182 Email: [email protected]

C.M. Rudenstam, Bohusgatan 26, S-41139 GÖTEBORG, SWEDEN. Tel: +46 31 164 511 Fax: +46 31 602 172 Email: [email protected]

Summary

Closed in December 2002 (opened in May 1993)
Final accrual: 473 patients

Objective

To compare the impact of avoiding axillary dissection in terms of the quality of life for older (≥60) patients who receive surgery and adjuvant tamoxifen.

Scheme

Update

See publications.

Related publications

International Breast Cancer Study Group. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10–93. J Clin Oncol 2006; 24: 337–344.

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials I–14).

Topics

Axillary lymph node dissection
Elderly patients
Postmenopausal patients
Tamoxifen

Keywords

Elderly patients, breast cancer, axillary clearance, tamoxifen, quality of life

***************************************************

Title

Adjuvant therapy for premenopausal patients with node-positive breast cancer who are suitable for endocrine therapy alone.

IBCSG Trial 11–93

Coordinator(s)

B. Thürlimann, Senologie-Zentrum Ostschweiz, Kantonsspital, CH-9007 ST GALLEN, SWITZERLAND. Tel: +41 71 494 1111 Fax: +41 71 494 6368 Email: [email protected]

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in November 1998 (opened in May 1993)
Final accrual: 174 patients

Objectives

To evaluate if the addition of chemotherapy (AC × 4) to endocrine therapy alone (ovarian function suppression (OFS), tamoxifen) improves outcome.
To assess quality of life.

Scheme

Update

See publications.

Related Publications

International Breast Cancer Study Group. Randomized controlled trial of ovarian function suppression plus tamoxifen versus the same endocrine therapy plus chemotherapy: Is chemotherapy necessary for premenopausal women with node-positive, endocrine responsive breast cancer? First results of International Breast Cancer Study Group Trial 11–93. The Breast 2001; 10 (Suppl 3):130–138 (Trial 11–93).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials I–14).

Topics

Hormonal therapy
Hormone-receptor-positive breast cancer
Node-positive breast cancer
Ovarian ablation
Premenopausal patients
Tamoxifen

Keywords

Breast cancer, endocrine therapy, ovarian ablation, AC, tamoxifen, quality of life

***************************************************

Title

Adjuvant therapy for post/perimenopausal patients with node-positive breast cancer who have estrogen-receptor-positive tumors. IBCSG Trial 12–93

Coordinator(s)

E. Simoncini, Oncologia Medica, Spedali Civili, Piazzale Spedali Civili 1, I-25123 BRESCIA, ITALY. Tel: +39 03 0399 5410 Fax: +39 03 0370 0017 Email: [email protected]

O. Pagani, IOSI, Oncology Institute of Southern Switzerland, c/o Ospedale Beata Vergine, CH-6850 MENDRISIO, SWITZERLAND. Tel: +41 91 811 3111 Fax: +41 91 811 3038 Email: [email protected]

Summary

Closed in August 1999 (opened in May 1993)
Final accrual: 452 patients

Objectives

To evaluate if toremifene is equally effective as tamoxifen in controlling breast cancer.
To assess quality of life.

Scheme

Update

See publications.

Related Publications

Gianni L, Panzini I, Li S, et al. for the IBCSG. Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group Trials. Cancer 2006; 106: 505–513. (Trials III, IV, VII, IX, 11–93, 12–93, 14–93).

International Breast Cancer Study Group. Toremifene and tamoxifen are equally effective for early-stage breast cancer: first results of International Breast Cancer Study Group Trials 12–93 and 14–93. Ann Oncol 2004; 15: 1749–1759 (Trials 12–93 and 14–93).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials 1–14).

Topics

Postmenopausal patients
Hormonal therapy
Hormone-receptor-positive breast cancer
Tamoxifen

Keywords

ER-positive breast cancer, post/perimenopausal patients, toremifene, tamoxifen, chemotherapy, quality of life

***************************************************

Title

Adjuvant therapy for premenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 13–93

Coordinator(s)

M. Colleoni, European Institute of Oncology, EIO, Unit of Research in Medical Senology, Department of Medicine, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 57489 439 Fax: +39 02 57489 581 Email: [email protected]

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in August 1999 (opened in May 1993)
Final accrual: 1294 patients

Objectives

To evaluate if a 16-week treatment-free interval between two sequential chemotherapy regimens (AC × 4, CMF × 3) improves outcome.
To evaluate if tamoxifen maintenance following chemotherapy improves outcome.
To assess quality of life.

Scheme

Update

See publications.

Related Publications

International Breast Cancer Study Group. Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: IBCSG Trial 13–93. J Clin Oncol 2006; 24: 1332–1341.

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials I–14).

Topics

Anthracyclines
Premenopausal patients
Node-positive breast cancer
Hormonal therapy
Tamoxifen

Keywords

Node-positive breast cancer, premenopausal patients, AC, CMF, tamoxifen, treatment-free interval, quality of life

***************************************************

Title

Adjuvant therapy for post perimenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone.

IBCSG Trial 14–93

Coordinator(s)

O. Pagani, IOSI, Oncology Institute of Southern Switzerland, Ospedale Beata Vergine, CH-6850 MENDRISIO, SWITZERLAND. Tel: +41 91 811 3111 Fax: +41 92 811 3038 Email: [email protected]

E. Simoncini, Oncologia Medica, Spedali Civili, Piazzale Spedali Civili 1, I-25123 BRESCIA, ITALY. Tel: +39 03 0399 5410 Fax: +39 03 0370 0017 Email: [email protected]

Summary

Closed in August 1999 (opened in May 1993)
Final accrual: 969 patients

Objectives

To evaluate if a 16-week treatment-free interval between two sequential chemotherapy regimens (AC × 4, CMF × 3) improves outcome.
To evaluate if toremifene is equally effective as tamoxifen in controlling breast cancer following completion of all chemotherapy.
To assess quality of life.

Scheme

Update

See publications.

Related Publications

Gianni L, Panzini I, Li S, et al. for the IBCSG. Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group Trials. Cancer 2006; 106: 505–513 (Trials III, IV, VII, IX, 11–93, 12–93, 14–93).

International Breast Cancer Study Group. Toremifene and tamoxifen are equally effective for early-stage breast cancer: first results of International Breast Cancer Study Group Trials 12–93, 14–93. Ann Oncol 2004; 15: 1749–1759 (Trials 12–93, 14–93).

Kitchen PRB, Smith HJ, Henderson MA, et al. Tubular carcinoma of the breast: Prognosis and response to adjuvant systemic therapy. ANZ J Surg 2001; 71: 27–31 (Trials 1–14).

Topics

Anthracyclines
Hormonal therapy
Node-positive breast cancer
Postmenopausal patients
Tamoxifen

Keywords

Node-positive breast cancer, post/perimenopausal patients, AC, CMF, tamoxifen, toremifene, treatment-free interval, quality of life

***************************************************

Title

High dose EC × 3 supported by PBSC versus EC/AC × 4 followed by CMF as adjuvant treatment for high-risk operable Stage II and Stage III breast cancer in premenopausal and young postmenopausal (<65 years) patients.

IBCSG Trial 15–95

Coordinator(s)

R. Basser, CSL Limited, 45 Poplar Road, Parkville, VIC 3052, AUSTRALIA. Tel: +61 3 9389 1569 Fax: +61 3 9388 2351 Email: [email protected]

M. Castiglione, IBCSG Coordinating Center, Effingerstr. 40, CH-3008 BERN, SWITZERLAND. Tel: +41 31 389 9391 Fax: +41 31 389 9235 Email: [email protected]

Summary

Closed in March 2000 (opened in July 1995)
Final accrual: 344 patients

Objectives

To evaluate if a regimen of high-dose chemotherapy (EC × 3) improves outcome when compared with standard dose chemotherapy (AC × 4 → CMF × 3) for patients with a high-risk of recurrence.
To evaluate quality of life.

Scheme

Update

See publications.

Related Publications

International Breast Cancer Study Group. Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer: results of International Breast Cancer Study Group Trial 15–95. J Clin Oncol 2006; 24: 370–378.

Topics

Anthracyclines
High-dose chemotherapy
Hormone-receptor-negative breast cancer
Node-positive breast cancer
Postmenopausal patients
Premenopausal patients
Tamoxifen

Keywords

High-risk operable Stage II/III breast cancer, high-dose chemotherapy, peripheral blood progenitor cells, tamoxifen, quality of life

***************************************************

Title

Adjuvant therapy for postmenopausal patients with operable breast cancer who have estrogen-receptor or progesterone-receptor-positive tumors. Tamoxifen versus letrozole versus tamoxifen followed by letrozole versus letrozole followed by tamoxifen.

BIG 1–98 / IBCSG Trial 18–98

Coordinator(s)

B. Thürlimann, Senologie-Zentrum Ostschweiz, Kantonsspital, CH-9007 St Gallen, SWITZERLAND. Tel: +41 71 494 1111 Fax: +41 71 494 6368 Email: [email protected]

Summary

Closed in May 2003 (opened in March 1998)
Final accrual: 8028 patients

Objectives

To compare letrozole × 5 years versus tamoxifen × 5 years.
To compare a sequence of adjuvant endocrine therapies versus a continuous course of a single endocrine agent.

Scheme

Update

Amendment 5 released in April 2005:
Unblinding and information of patients on treatment arm A (Tamoxifen).

Substudies

New Bone substudy opened May 2004, target accrual: 660 patients.
Cognitive Function substudy opened April 2005, target accrual: 296 patients
Fingernail Pilot substudy opened April 2005, target accrual: 60 patients
Bone Mineral Density substudy closed February 2003.
General Safety/Lipid Profile substudy closed February 2003.

First results published, see publications.

Related Publications

BIG 1–98 Collaborative. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. New Engl J Med 2005; 353: 2747–2757 (Trial 18–98).

Topics

Aromatase inhibitors
Hormone-receptor-positive breast cancer
Postmenopausal patients
Tamoxifen

Keywords

Hormone-receptor-positive breast cancer, letrozole, tamoxifen, mono/ sequential therapy

***************************************************

Title

Maintenance chemotherapy in hormone non-responsive breast cancer: low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer.

IBCSG Trial 22–00

Coordinator(s)

M. Colleoni, European Institute of Oncology, EIO, Unit of Research in Medical Senology, Department of Medicine, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 574 89 439 Fax: +39 02 57489 581, Email: [email protected]

Summary

Date of activation: November 2000
Target accrual: 900 patients

Objective

To evaluate the efficacy of a low-dose chemotherapy regimen, hypothesized to have anti-angiogenic activity, administered following a standard chemotherapy program in patients whose tumors are not endocrine therapy-responsive.

Scheme

Update

Amendment 3: November 2005.
Serum Substudy: opened June 2002, target accrual: 170 patients.

Related Publications

Price KN, Goldhirsch A for the IBCSG. Clinical trial update: International Breast Cancer Study Group. Breast Cancer Res 2005; 7: 252–254 (commentary).

Topics

Hormone-receptor-negative breast cancer
Low-dose chemotherapy
Premenopausal patients or postmenopausal patients
Elderly patients and young patients
Treatment tailoring

Keywords

Hormone non-responsive breast cancer, anti-angiogenesis, maintenance chemotherapy, CM maintenance, tailored chemotherapy, quality of life

***************************************************

Title

A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node-negative breast cancer and micrometastases in the sentinel node.

IBCSG Trial 23–01

Coordinator(s)

V. Galimberti, European Institute of Oncology EIO, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 57489 717 Fax: +39 02 57489 780, Email: [email protected]

S. Zurrida, European Institute of Oncology EIO, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 57489 608 / 215 Email: [email protected]

U. Veronesi, European Institute of Oncology EIO, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 57224 / 215 Fax: +39 02 57489 210 Email: [email protected]

Summary

Date of activation: December 2001
Target accrual: 1960 patients

Objective

To compare axillary dissection versus no axillary dissection in terms of disease-free survival in patients with one micrometastasis in a sentinel node.

Scheme

Patients with

Clinically node-negative breast cancer
Size of largest tumour lesion ≤ 5 cm
Sentinel node biopsy
SN micrometastases ≤ 2 mm

Update

Amendment 2: June 2006.

Related Publications

None available

Topics

Axillary lymph node dissection
Postmenopausal patients
Premenopausal patients
Sentinel node micrometastasis
Sentinel node resection

Keywords

Clinically node-negative breast cancer, sentinel node micrometastasis, axillary dissection, quality of life

***************************************************

Title

Suppression of Ovarian Function Trial (SOFT).

A Phase III trial evaluating the role of ovarian function suppression (OFS) and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer. Tamoxifen versus OFS + tamoxifen versus OFS + exemestane.

BIG 2–02/IBCSG Trial 24–02

Coordinator(s)

BIG: P. Francis, Peter MacCallum Cancer Institute, St Andrews Place, 3002 East Melbourne, VIC, AUSTRALIA. Tel: +61 3 965 61190 Fax: +61 3 965 61408, Email: [email protected]

US Intergroup: G. Fleming, University of Chicago Medical Center, Section of Hematology/Oncology, 5841 South Maryland Ave, MC 2115, CHICAGO, IL 60637-1470, USA. Tel: +1 773 702 6712 Fax: +1 773 702 0963, Email: [email protected]

Summary

Date of activation: August 2003
Target accrual: 3000 patients

Objectives

To evaluate the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer.
To assess quality of life.

Scheme

Update

Amendment 1: October 2005.

Related Publications

Dellapasqua S, Castiglione-Gertsch M. The choice of systemic adjuvant therapy in receptor-positive early breast cancer. Eur J Cancer 2005; 41: 357–364 (commentary).

Dellapasqua S, Colleoni M, Gelber RD, Goldhirsch A. Adjuvant endocrine therapy for premenopausal women with early breast cancer. J Clin Oncol 2005; 23: 1736–1750 (commentary).

Price KN, Goldhirsch A for the IBCSG. Clinical trial update: International Breast Cancer Study Group. Breast Cancer Res 2005; 7: 252–254 (commentary).

Topics

Aromatase inhibitors
Hormone-receptor-positive breast cancer
Ovarian function suppression
Premenopausal patients
Tamoxifen
Treatment tailoring
Young patients

Keywords

Endocrine-responsive breast cancer, premenopausal patients, ovarian function suppression, tamoxifen, exemestane, tailored treatment, quality of life

***************************************************

Title

Tamoxifen and Exemestane Trial (TEXT)

A Phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer. Ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane.

BIG 3–02/IBCSG Trial 25–02

Coordinator(s)

BIG: O. Pagani, IOSI, Oncology Institute of Southern Switzerland, Ospedale Beata Vergine, 6850 MENDRISIO, SWITZERLAND. Tel: +41 79 208 77 85 Fax: +41 91 811 30 27 Email: [email protected]

US Intergroup: B. Walley, Tom Baker Cancer Centre, 1331 – 29 St. N.W., CALGARY, ALBERTA, CANADA. Tel: +1 403 521 3688 Fax: +1 403 283 1651, Email: [email protected]

Summary

Date of activation: August 2003
Target accrual: 1845 patients

Objectives

To compare GnRH analogue plus exemestane versus GnRH analogue plus tamoxifen for premenopausal women with endocrine-responsive breast cancer.
To assess quality of life.

Scheme

Update

Amendment 1: October 2005.

Related Publications

Dellapasqua S, Castiglione-Gertsch M. The choice of systemic adjuvant therapy in receptor-positive early breast cancer. Eur J Cancer 2005; 41: 357–364 (commentary).

Dellapasqua S, Colleoni M, Gelber RD, Goldhirsch A. Adjuvant endocrine therapy for premenopausal women with early breast cancer. J Clin Oncol 2005; 23: 1736–1750 (commentary).

Price KN, Goldhirsch A for the IBCSG. Clinical trial update: International Breast Cancer Study Group. Breast Cancer Res 2005; 7: 252–254 (commentary).

Topics

Aromatase inhibitors
Hormone-receptor-positive breast cancer
Ovarian function suppression
Premenopausal patients
Tamoxifen
Treatment tailoring
Young patients

Keywords

Endocrine-responsive breast cancer, premenopausal patients, ovarian function suppression, tamoxifen, exemestane, tailored treatment, quality of life

***************************************************

Title

Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE) A Phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer who receive endocrine therapy.

Chemotherapy + OFS + tamoxifen/exemestane versus OFS + tamoxifen/ exemestane.

BIG 4–02/IBCSG Trial 26–02

Coordinator(s)

BIG: R. Torrisi, European Institute of Oncology, EIO, Unit of Research in Medical Senology, Department of Medicine, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 574 89 482 Fax +39 02 57489 581 Email: [email protected]

US Intergroup: E.A. Perez, Mayo Clinic Jacksonville, 4500 San Pablo Road S, JACKSONVILLE, FL 32224-1865, USA. Tel: +1 904 953 2000 Fax: +1 904 953 2315 Email: [email protected]

Summary

Date of activation: August 2003
Target accrual: 1750 patients

Objectives

To evaluate the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer who receive endocrine therapy.
To assess quality of life.

Scheme

Update

Amendment 1: October 2005.

Related Publications

Dellapasqua S, Castiglione-Gertsch M. The choice of systemic adjuvant therapy in receptor-positive early breast cancer. Eur J Cancer 2005; 41: 357–364 (commentary).

Dellapasqua S, Colleoni M, Gelber RD, Goldhirsch A. Adjuvant endocrine therapy for premenopausal women with early breast cancer. J Clin Oncol 2005; 23: 1736–1750 (commentary).

Price KN, Goldhirsch A for the IBCSG. Clinical trial update: International Breast Cancer Study Group. Breast Cancer Res 2005; 7: 252–254 (commentary).

Topics

Aromatase inhibitors
Hormone-receptor-positive breast cancer
Ovarian function suppression
Premenopausal patients
Tamoxifen
Treatment tailoring
Young patients

Keywords

Endocrine-responsive breast cancer, ovarian function suppression, chemotherapy, tamoxifen, exemestane, tailored treatment, quality of life

***************************************************

Title

Chemotherapy for radically resected loco-regional relapse.

BIG 1-02/IBCSG Trial 27–02/NSABP Protocol B-37

Coordinator(s)

BIG

S. Aebi, Institute of Medical Oncology, Inselspital, CH-3010 BERN, SWITZERLAND. Tel: +41 31 632 4114 Fax: +41 31 382 1237 Email: [email protected]

NSABP

I. Wapnir, Stanford University Medical Center, 300 Pasteur Drive H-3625, STANFORD, CA 94305-1353, USA. Tel: +1 650 736 13 53 Fax: +1 650 736 16 63 Email: [email protected]

Summary

Date of activation: July 2002
Target accrual: 977 patients

Objective

To evaluate the efficacy of adjuvant chemotherapy after radical local treatment of a first loco-regional recurrence of breast cancer.

Scheme

Update

Amendment 1 released December 2004.

Related Publications

None available

Topics

Loco-regional relapse

Keywords

Breast cancer, loco-regional relapse, chemotherapy, quality of life

***************************************************

Title

Chemotherapy adjuvant study for women at advanced Age (CASA) Phase III trial evaluating the role of adjuvant pegylated liposomal doxorubicin (PLD) for women (age 66 years or older) with endocrine non-responsive breast cancer who are not suitable for being offered a “standard chemotherapy regimen”.

BIG 1–05/IBCSG Trial 32–05

Coordinator(s)

D. Crivellari, Centro di Riferimento Oncologico, Via Pedemontana Occidentale 12, I-33081 AVIANO, ITALY. Tel: +39 0434 659 653 Fax: +39 0434 652 182 Email: [email protected]

S. Dellapasqua, European Institute of Oncology, EIO, Unit of Research in Medical Senology, Department of Medicine, Via Ripamonti 435, I-20141 MILANO, ITALY. Tel: +39 02 57489 482 Fax: +39 02 57489 581 Email: [email protected]

A. Hamilton, MBBS FRACP, Medical Oncologist, Sydney Cancer Centre, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, SYDNEY 2050, AUSTRALIA. Tel: +61 2 9515 5894 Fax: +61 2 9519 1546 Email: [email protected]

Summary

Date of activation: August 2005
Target accrual: 1296 patients

Objectives

To investigate the role of PLD as adjuvant chemotherapy for older postmenopausal women for whom chemotherapy is indicated, but standard regimens, derived from trials in younger women, are assumed to be too toxic or inconvenient.
To evaluate quality of life.
The randomization options enable physicians and patients to choose which control group is appropriate for a given patient.

Scheme

Update

None available

Related Publications

Price KN, Goldhirsch A for the IBCSG. Clinical trial update: International Breast Cancer Study Group. Breast Cancer Res 2005; 7: 252–254 (commentary).

Topics

Anthracyclines
Elderly patients
Hormone-receptor-negative breast cancer
Low-dose chemotherapy
Postmenopausal patients

Keywords

Endocrine non-responsive breast cancer, elderly patients (aged 66 years and older), pegylated liposomal doxorubicin, low-dose metronomic CM, quality of life