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Spanish Breast Cancer Research Group (GEICAM)

Published online by Cambridge University Press:  04 December 2006

Abstract

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

  1. FAC versus CMF as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group. GEICAM/8701

  2. Phase III study of concomitant versus sequential chemohormonotherapy (EC plus tamoxifen) as adjuvant chemotherapy for node-positive postmenopausal women. GEICAM/9401

  3. High-dose DICEP chemotherapy versus observation in metastatic breast cancer patients with monotopic disease responding to induction chemotherapy with paclitaxel plus epirubicin. Phase III GEICAM trial. GEICAM/9601

  4. Vinorelbine infusion over 96 hours in heavily pre-treated patients with metastatic breast cancer: a cooperative study by the GEICAM group. GEICAM/9702

  5. Phase II trial of gemcitabine in combination with vinorelbine in patients with metastatic breast cancer resistant to anthracyclines. GEICAM/9704

  6. A phase II trial for evaluation of sequential doxorubicin and docetaxel as first-line treatment in metastatic breast cancer. GEICAM/9801

  7. A multicenter phase III randomized trial comparing docetaxel with doxorubicin and cyclophosphamide (TAC) versus 5-fluorouracil with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of operable breast cancer patients with negative axillary lymph nodes. TARGET 0 / GEICAM/9805

  8. A multicenter phase III randomized trial to compare the sequential and the concomitant administration of doxorubicin and docetaxel, as first-line chemotherapy treatment for metastatic breast disease. GEICAM/9903

  9. Docetaxel plus gemcitabine administered every other week as first-line treatment for metastatic breast cancer. GEICAM/9904

  10. Weekly docetaxel as neo-adjuvant treatment in stage II and III breast cancer. GEICAM/9905

  11. A multicenter phase III randomized trial comparing 5-fluorouracil with epirubicin and cyclophosphamide (FEC) versus 5-fluorouracil with epirubicin and cyclophosphamide (FEC) followed by weekly paclitaxel as adjuvant treatment of operable breast cancer patients with positive axillary lymph nodes. GEICAM/9906

  12. An open, multicenter randomized phase IV trial for the administration of pamidronate to breast cancer patients with bone metastatic disease. GEICAM/2000-01

  13. A randomized phase III treatment to compare the administration of vinorelbine versus vinorelbine plus gemcitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. GEICAM/2000-04

  14. Maintenance phase III/IV study for the administration of Caelyx versus no treatment, after induction chemotherapy for metastatic breast cancer disease. GEICAM/2001-01

  15. A multicenter, cross-over, randomized trial with exemestane versus anastrozole as first-line hormonal treatment of postmenopausal women with metastatic breast cancer disease and positive hormone receptors. GEICAM/2001-03

  16. A multicenter, open-label randomized phase III trial for the administration of zoledronate to patients with advanced breast cancer disease and non-symptomatic bone metastasis. GEICAM/2001-05

  17. A multicenter phase II trial to evaluate the administration of gemcitabine with doxorubicin and paclitaxel (GAT) as neo-adjuvant treatment of stage III disease breast cancer patients. GEICAM/2002–01

  18. A phase II trial to evaluate the administration of doxorubicin with cyclophosphamide (AC) followed by weekly docetaxel (T) as neo-adjuvant treatment of stage II disease breast cancer patients. GEICAM/2002–03

  19. A multicenter, open-label, randomized phase III trial comparing six courses of FAC (fluorouracil, doxorubicin, cyclophosphamide) with four courses of FAC followed by 8-weekly administrations of Taxol in the adjuvant treatment of node-negative patients with operable breast cancer. GEICAM/2003–02

  20. A multicenter, open-label, randomized phase III trial comparing epirubicin plus cyclophosphamide (EC) followed by docetaxel (T) with epirubicin plus docetaxel (ET) followed by capecitabine (X) in the adjuvant treatment of node-positive patients with operable breast cancer. GEICAM/2003–10

  21. Open-label, no randomized, phases I–II of the treatment with Myocet/Taxotere/Herceptin as primary antineoplasic treatment in newly diagnosed breast cancer patients with HER2neu overexpression. GEICAM/2003–03

  22. Phase IV.II clinical trial with the combination of pegylated liposomal doxorubicin, cyclophosphamide and trastuzumab in patients with metastatic breast cancer with overexpression HER2neu. GEICAM/2004–05

  23. Randomized clinical trial to compare the benefit of adding trastuzumab to the combination of capecitabine plus vinorelbine as second-line treatment for patients with locally advanced non-operable breast cancer or metastatic breast cancer with overexpression of HER2, who have progressed to a previous line of treatment for metastatic disease that included trastuzumab in combination with taxanes. GEICAM/2004–06

  24. Phase IV.II clinical trial, multicenter, for administration of capecitabine concomitant to radiotherapy in patients with locally advanced breast cancer and HER2neu negatives. GEICAM/2005–01

  25. Phase IV.III, multicenter, open, randomized treatment study to evaluate the efficacy of maintenance therapy with capecitabine after standard chemotherapy with anthracyclines in patients with metastatic breast cancer. GEICAM/2005–04

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. 172 - 205 , e59
Copyright
© 2006 Cambridge University Press

GEICAM – Contact Details

Country

Spain

Chair

Dr M. Martín, Servicio de Oncología Médica, Hospital Clínico Universitario San Carlos, C/Professor Martín Lagos s/n, 28040 MADRID, SPAIN. Tel: +34 91 330 3546 Fax: +34 91 399 2627

Address

GEICAM (Spanish Breast Cancer Research Group,) Avda. de los Pirineos, 7 Planta 1a Oficina 1–14, 28700 San Sebastián de los Reyes, MADRID, SPAIN. Tel: +34 91 659 28 70 Fax: +34 91 651 04 06 Email:

GEICAM – Study Details

Title

FAC versus CMF as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group. GEICAM/8701

Coordinator(s)

M. Martin, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

Summary

  • Opened in November 1987
  • Accrual completed in December 1991 with 989 patients

Objective

  • To determine the relative efficacy of doxorubicin versus methotrexate in combination with intravenous cyclophosphamide and 5-fluorouracil, as adjuvant chemotherapy for operable breast cancer.

Scheme

Update

  • Presented (Poster) at the 37th ASCO Annual Meeting (2001). Presented (Oral Presentation) at the 8th Spanish Society of Clinical Oncology Biannual Meeting (2001).

Related Publications

Results Published in Ann Oncol 2003; 14 (6): 833–842.

Topics

  • Adjuvant treatment
  • Anthracyclines

Keywords

Adjuvant treatment, anthracyclines

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

Title

Phase III study of concomitant versus sequential chemohormonotherapy (EC plus tamoxifen) as adjuvant chemotherapy for node-positive postmenopausal women. GEICAM/9401

Coordinator(s)

C. Picó, Servicio de Oncología Médica, Hospital General de Alicante, Pza Dr. Gómez Ulla, 15, 03013 ALICANTE, SPAIN. Fax: +34 96 593 8448 Email:

Summary

  • Opened in November 1994
  • Accrual completed in June 2001 with 485 patients

Objective

  • To determine the best way to administer postsurgical chemotherapy plus tamoxifen (sequential versus concomitant) in node-positive postmenopausal breast cancer patients.

Scheme

Update

  • Final results were presented as oral communication at the 38th ASCO Annual Meeting (2002).

Related Publications

Results published in Ann Oncol 2004; 15 (1): 79–87.

Topics

  • Adjuvant treatment
  • Tamoxifen
  • Hormonal therapy

Keywords

Adjuvant treatment, tamoxifen, hormonal therapy

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

Title

High-dose DICEP chemotherapy versus observation in metastatic breast cancer patients with monotopic disease responding to induction chemotherapy with paclitaxel plus epirubicin. Phase III GEICAM trial. GEICAM/9601

Coordinator(s)

M. Martín, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

Summary

  • Opened in December 1996
  • Accrual completed in October 2000 with 52 patients

Objective

  • To determine the efficacy of high-dose consolidation DICEP chemotherapy (HD-DICEP) in prolonging progression-free survival (PFS) of chemotherapy responsive metastatic breast cancer (MBC) patients with monotopic disease.

Scheme

Consolidation high-dose chemotherapy (DICEP) was according to the scheme of University of Washington Medical Center.This consisted of two courses of etoposide 150 mg/m2twice daily on days 1–3, cisplatin 75 mg/m2on days 1 and 5, and cyclophosphamide 2.25 mg/m2 on days 4 and 5.The second course of consolidation chemotherapy was administered 6–8 weeks after the first.

Update

None available

Related Publications

Results published in Revista de Oncología 2003; 5: 148–155.

Topics

  • High-dose chemotherapy
  • Monotopic disease

Keywords

High-dose chemotherapy, monotopic disease

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

Title

Vinorelbine infusion over 96 hours in heavily pre-treated patients with metastatic breast cancer: a cooperative study by the GEICAM group. GEICAM/9702

Coordinator(s)

C. Jara, Servicio de Oncología Médica, Fundación Hospitalaria de Alcorcón, Budapest, 1, 28922 Alcorcón, MADRID, SPAIN.

Summary

  • Opened in May 1996
  • Accrual completed in March 1999 with 48 patients

Objective

  • To assess the activity of vinorelbine in a 96-hour continuous infusion in patients with metastatic breast cancer with poor prognosis.

Scheme

Vinorelbine (8 mg/m2) injected slowly over 5–10 minutes on day 1, followed by 8 mg/m2on days 1–4 in continuous infusion.

Update

None available

Related Publications

Results published in Clin Breast Cancer 2003; 3 (6): 399–404.

Topics

  • Innovative schedules
  • Multiple drug resistance

Keywords

Innovative schedules, multiple drug resistance

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

Title

Phase II trial of gemcitabine in combination with vinorelbine with metastatic breast cancer resistant to anthracyclines. GEICAM/9704

Coordinator(s)

F. Lobo, Servicio de Oncología Médica, Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, 28040 MADRID, SPAIN.

Summary

  • Opened in April 1998
  • Accrual completed in December 2000 with 25 patients

Objective

  • To evaluate response rate and toxicity of a combination of gemcitabine and vinorelbine in patients with metastatic breast cancer

Scheme

All patients had previously received anthracyclines. Treatment consisted of gemcitabine 1200 mg/m2and vinorelbine 30 mg/m2on days 1 and weeks.

Update

  • Presented (Proceedings) at the 38th ASCO Annual Meeting (2002)

Related Publications

Results published in Clin Breast Cancer 2003; 4 (1): 46–50.

Topics

  • Multiple drug resistance
  • Innovative schedules

Keywords

Multiple drug resistance, innovative schedules

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

Title

A phase II trial for evaluation of sequential doxorubicin and docetaxel as first-line treatment in metastatic breast cancer. GEICAM/9801

Coordinator(s)

E. Alba, Servicio de Oncología Médica, Hospital U. Virgen de la Victoria, Colonia Santa Inés s/n, 29010 MÁLAGA, SPAIN. Email:

Summary

  • Opened in April 1997
  • Accrual completed in December 1999 with 81 patients

Objective

  • To evaluate the efficacy and the toxicity profile of the sequential administration of doxorubicin and docetaxel as first-line chemotherapy in metastatic breast cancer.

Scheme

Doxorubicin 75 mg/m2day 1 every 3 weeks (three courses) followed by docetaxel 100 mg/m2day 1 every 3 weeks (three courses).

Update

  • Presented (Poster) at the Conference of Federation of Spanish Societies of Oncology (2000).
  • Presented (Poster) at the 19th Conference of Senology and Mammary Pathology (2000).
  • Presented (Poster) at the 36th ASCO Annual Meeting (2000).
  • Presented (Oral Presentation) at the 4th European Conference of Breast Cancer (2002).

Related Publications

Results Published in Cancer Res Treat 2003; 77: 1–8.

Topics

  • Metastatic breast cancer
  • Anthracyclines
  • Taxanes

Keywords

Metastatic breast cancer, anthracyclines, taxanes

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

Title

A multicenter phase III randomized trial comparing docetaxel with doxorubicin and cyclophosphamide (TAC) versus 5-fluorouracil with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of operable breast cancer patients with negative axillary lymph nodes. TARGET 0 / GEICAM/9805

Coordinator(s)

M. Martin, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, MADRID, SPAIN. Email:

A. Barnadas, Servicio de Oncología Médica, Hospital Germans Trias i Pujol, BADALONA-BARCELONA, SPAIN. Email:

A. Lluch, Servicio de Oncología Médica, Hospital Clínico Universitario, VALENCIA, SPAIN. Email:

Summary

  • Opened in June 1999
  • Accrual completed in March 2003 with 1066 patients

Objective

  • To determine the relative efficacy and toxicity of docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus 5-fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for high-risk (St Gallen criteria) node-negative breast cancer.

Scheme

Update

  • Presented (Poster) at the 27th Annual Symposium of the American Society of Breast Disease (ABSD) (2003).
  • Presented (Poster) at the 41st ASCO Annual Meeting (2005).

Related Publications

None available

Topics

  • Node-negative breast cancer
  • Anthracyclines
  • Taxanes

Keywords

Node-negative breast cancer, anthracyclines, taxanes

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

Title

A multicenter phase III randomized trial to compare the sequential and the concomitant administration of doxorubicin and docetaxel, as first-line chemotherapy treatment for metastatic breast disease. GEICAM/9903

Coordinator(s)

E. Alba, Servicio de Oncología Médica, Hospital U. Virgen de la Victoria, Colonia Santa Inés s/n, 29010 MÁLAGA, SPAIN.

Summary

  • Opened in December 1999
  • Accrual completed in December 2001 with 144 patients

Objective

  • To compare the hematological toxicity and efficacy of sequential versus concomitant administration of doxorubicin and docetaxel as metastatic breast cancer first-line treatment.

Scheme

Randomization

  • Arm A:Sequential treatment with doxorubicin (A) (75 mg/m2q 21 days) and docetaxel (T) (100 mg/m2q 21 days).Patients with previous anthracyclines received A × 2 followed by T34.Patients without previous anthracyclines received A × 3 followed by T × 3.
  • Arm B:Concomitant treatment with A (50 mg/m2) plus T (75 mg/m2) q 21 days for 3 cycles, followed by 3 cycles of T (100 mg/m2q 21 days) in patients with previous anthracyclines, or by A plus T (50 mg/m2plus 75 mg/m2) q 21 days for 3 cycles in patients without previous anthracyclines.

Update

  • Presented (Proceedings) at the 38th ASCO Annual Meeting (2002).
  • Presented (Oral Presentation) at the 39th ASCO Annual Meeting (2003).
  • Presented (Oral Presentation) at the Spanish Society of Clinical Oncology Biannual Meeting (2003).

Related Publications

Results published in J Clin Oncol 2004; 22 (13): 2587–2593.

Topics

  • Taxanes
  • Anthracyclines
  • Metastatic breast cancer

Keywords

Taxanes, anthracyclines, metastatic breast cancer

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

Title

Docetaxel plus gemcitabine administered every other week as first-line treatment for metastatic breast cancer. GEICAM/9904

Coordinator(s)

A. Pelegrí, Servicio de Oncología Médica, Hospital Universitario Sant Joan, C/Sant Joan s/n, 43201 Reus, TARRAGONA, SPAIN.

Summary

  • Opened in November 1999
  • Accrual completed in November 2001 with 52 patients

Objective

  • To assess the toxicity and efficacy of the combination of docetaxel and gemcitabine every 2 weeks as first-line therapy in metastatic breast cancer.

Scheme

Update

  • Presented (Poster) at the 24th Annual San Antonio Breast Cancer Symposium (2001).
  • Presented (Poster) at the 38th ASCO Annual Meeting (2002).
  • Presented at the 8th International Oncology Conference (St Gallen 2003).
  • Presented (Proceedings) at the 39th ASCO Annual Meeting (2003).

Related Publications

Results published in Sem Oncol 2004; 31 (2 Suppl 4): 20–24.

Topics

  • Metastatic breast cancer
  • Taxanes
  • Gemcitabine

Keywords

Metastatic breast cancer, taxanes, gemcitabine

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

Title

Weekly docetaxel as neo-adjuvant treatment in stage II and III breast cancer. GEICAM/9905

Coordinator(s)

L. García Estévez, Servicio de Oncología Médica, Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, 28040 MADRID, SPAIN.

Summary

  • Opened in July 1999
  • Accrual completed in August with 56 patients

Objective

  • Clinical and pathological response rate.

Scheme

Update

  • Presented (Poster) at the 23rd Annual San Antonio Breast Cancer Symposium (2000).
  • Presented (Proceedings) at the 37th ASCO Annual Meeting (2001).
  • Presented (Oral Presentation) at the 4th European Conference of Breast Cancer (2002).

Related Publications

Results published in Clin Cancer Res 2003; 9: 686–692.

Topics

  • Neo-adjuvant treatment
  • Taxanes

Keywords

Neo-adjuvant treatment, taxanes

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

Title

A multicenter phase III randomized trial comparing 5-fluorouracil with epirubicin and cyclophosphamide (FEC) versus 5-fluorouracil with epirubicin and cyclophosphamide (FEC) followed by weekly paclitaxel as adjuvant treatment of operable breast cancer patients with positive axillary lymph nodes. GEICAM/9906

Coordinator(s)

A. Rodríguez Lescure, Servicio de Oncología Médica, Hospital General U. De Elche, 03203 ELCHE-ALICANTE, SPAIN.

J.M. López Vega, Servicio de Oncología Médica, Hospital U. Marqués de Valdecilla, Av. De Valdecilla s/n, 39008 SANTANDER, SPAIN. Email:

E. Aranda, Servicio de Oncología Médica, H.U. Reina Sofía, Av. Menéndez Pidal s/n, 14004 CÓRDOBA, SPAIN.

Summary

  • Opened in December 1999
  • Accrual completed in May 2002 with 1250 patients

Objective

  • To determine the relative efficacy and toxicity of 5-fluorouracil with epirubicin and cyclophosphamide (FEC) versus 5-fluorouracil with epirubicin and cyclophosphamide (FEC) followed by weekly paclitaxel as chemotherapy for operable breast cancer patients with positive axillary lymph nodes.

Scheme

Update

  • First interim efficacy analysis presented (Oral Presentation) at the Spanish Society of Clinical Oncology Biannual Meeting (2003).
  • First interim efficacy analysis presented (Poster) at the 26th Annual San Antonio Breast Cancer Symposium (2003).
  • Presented (Oral Presentation) at the 28th Annual San Antonio Breast Cancer Symposium (2005).

Related Publications

None available

Topics

  • Adjuvant treatment
  • Paclitaxel

Keywords

Adjuvant treatment, paclitaxel

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

Title

An open, multicenter randomized phase IV trial for the administration of pamidronate to breast cancer patients with bone metastatic disease. GEICAM/2000-01

Coordinator(s)

A. Lluch, Servicio de Oncología Médica, Hospital Clínico U. De Valencia, Av. Blasco Ibáñez, 17, 46010 VALENCIA, SPAIN.

A. Barnadas i Molins, Servicio de Oncología Médica, Hospital Germans Trias i Pujol, Cta. Canyet s/n, 8915 BADALONA-BARCELONA, SPAIN.

Summary

  • Opened in May 2000
  • Accrual completed in December 2002 with 150 patients

Objective

  • To compare continuous administration of pamidronate for 18 months versus administration of aredia for 6 months followed by 6 months without treatment followed by administration of pamidronate for 6 months, to evaluate differences in time to first skeletal bone event in both arms.

Scheme

Randomization

  • Arm A:Pamidronate 90 mg every 3–4 weeks for 18 months.
  • Arm B:Pamidronate 90 mg every 3–4 weeks for 6 months, then, 6 months at rest, followed by pamidronate 90 mg every 3–4 weeks for 6 months.

Update

Presented (Poster) at the 28th Annual San Antonio Breast Cancer Symposium (2005).

Related Publications

None available

Topics

  • Bisphosphonates
  • Symptomatic bone metastasis

Keywords

Bisphosphonates, symptomatic bone metastasis

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

Title

A randomized phase III treatment to compare the administration of vinorelbine versus vinorelbine plus gemcitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. GEICAM/2000-04

Coordinator(s)

M. Martin, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

Summary

  • Opened in December 2000
  • Accrual completed in March 2005 with 252 patients

Objective

  • To compare progression-free survival among treatment arms A and B in patients with metastatic breast cancer who have previously been treated with anthracyclines and taxanes.

Scheme

Randomization

  • Arm A:Vinorelbine 30 mg/m2days 1 and 8, every 3 weeks.
  • Arm B:Vinorelbine 30 mg/m2days 1 and 8, every 3 weeks.Gemcitabine 1200 mg/m2days 1 and 8, every 3 weeks.

Patients will receive study treatment until progression of the disease or unacceptable toxicity.

Update

None available

Related Publications

None available

Topics

  • Metastatic breast cancer
  • Gemcitabine
  • Innovative schedules

Keywords

Metastatic breast cancer, gemcitabine, innovative schedules

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

Title

Maintenance phase III/IV study for the administration of Caelyx versus no treatment, after induction chemotherapy for metastatic breast cancer disease. GEICAM/2001-01

Coordinator(s)

E. Alba, Servicio de Oncología Médica, Hospital U. Virgen de la Victoria, Colonia Santa Inés s/n, 29010 MÁLAGA, SPAIN.

Summary

  • Opened in June 2002
  • Target: 154 patients

Objective

  • To evaluate time to disease progression after maintenance treatment with pegilated lyposomal doxorubicin (Caelyx) in patients with complete or partial response, or stable disease, versus nonmaintenance treatment.

Scheme

Update

  • Number of registered patients 254 as of March 2006.
  • Accrual: 135 patients as of March 2006.

Related Publications

None available

Topics

  • Induction chemotherapy
  • Liposomal doxorubicin
  • Metastatic breast cancer

Keywords

Induction chemotherapy, liposomal doxorubicin, metastatic breast cancer

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

Title

A multicenter, cross-over, randomized trial with exemestane versus anastrozole as first-line hormonal treatment of postmenopausal women with metastatic breast cancer disease and positive hormone receptors. GEICAM/2001-03

Coordinator(s)

A. Llombart, Servicio de Oncología Médica, Instituto Valenciano de Oncología, C/Professor Beltrán Baguera 8, 9, 19, 46009 VALENCIA, SPAIN.

Summary

  • Opened in June 2001
  • Accrual completed in March 2004 with 103 patients

Objective

  • To evaluate objective response rate.

Scheme

Update

None available

Related Publications

None available

Topics

  • Aromatase inhibitors
  • Hormonal therapy

Keywords

Aromatase inhibitors, hormonal therapy

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

Title

A multicenter, open-label randomized phase III trial for the administration of zoledronate to patients with advanced breast cancer disease and non-symptomatic bone metastasis. GEICAM/2001-05

Coordinator(s)

A. Lluch, Servicio de Oncología Médica, Hospital Clínico U. De Valencia, Av. Blasco Ibáñez, 17, 46010 VALENCIA, SPAIN.

A. Barnadas i Molins, Servicio de Oncología Médica, Hospital Germans Trias i Pujol, Cta. Canyet s/n, 8915 BADALONA-BARCELONA, SPAIN.

Summary

  • Opened in April 2002
  • Target: 224 patients

Objective

  • To assess zoledronate efficacy (combined with hormone therapy or chemotherapy) to delay bone metastasis symptoms in breast cancer patients with at least one single bone disease location.

Scheme

Randomization

  • Arm A:Zoledronate 4 mg every 3–4 weeks.Study treatment will be maintained until symptoms related to bone disease appear, or during 1 year (whichever occurs first).
  • Arm B:Patients will not receive any treatment with bisphosphonates until symptoms related to bone disease appear, or during 1 year (whichever occurs first).

Update

  • Accrual: 89 patients as of March 2006.

Related Publications

None available

Topics

  • Bisphosphonates
  • Non-symptomatic bone metastasis

Keywords

Bisphosphonates, non-symptomatic bone metastasis

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

Title

A multicenter phase II trial to evaluate the administration of gemcitabine with doxorubicin and paclitaxel (GAT) as neo-adjuvant treatment of stage III disease breast cancer patients. GEICAM/2002–01

Coordinator(s)

P. Sánchez-Rovira, Servicio de Oncología Médica, Complejo Hospitalario Ciudad de Jaén, Av. Ejército Español s/n, 23007 JAÉN, SPAIN.

A. Antón, Servicio de Oncología Médica, Hospital U. Miguel Servet, Av. Isabel La Católica 1 y 3, 50009 ZARAGOZA, SPAIN.

Summary

  • Opened in January 2003
  • Accrual completed in July 2004 with 46 patients

Objective

  • To determine the rate of pathological complete response obtained with GAT combination of drugs in the neo-adjuvant treatment of stage III disease breast cancer patients.

Scheme

  • A:Doxorubicin 40 mg/m2, day 1 every other week.
  • T:Paclitaxel 150 mg/m2day 2 every other week.
  • G:Gemcitabine 2000 mg/m2day 2 every other week.

This is defined a cycle.Each cycle is administered every 2 weeks, for a total of 6 cycles, prior to primary surgery of the breast.

Update

  • Presented (Poster) at the 27th Annual San Antonio Breast Cancer Symposium (2004).
  • Presented (Proceedings) at the 41st ASCO Annual Meeting (2005).

Related Publications

None available

Topics

  • Neo-adjuvant treatment
  • Gemcitabine
  • Paclitaxel

Keywords

Neo-adjuvant treatment, gemcitabine, paclitaxel

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

Title

A phase II trial to evaluate the administration of doxorubicin with cyclophosphamide (AC) followed by weekly docetaxel (T) as neo-adjuvant treatment of stage II disease breast cancer patients. GEICAM/2002–03

Coordinator(s)

L. García Estévez, Servicio de Oncología Médica Fundación Jiménez Díaz, Av. Reyes Católicos, 2, 28040 MADRID, SPAIN. Email:

J.M. López Vega, Servicio de Oncología Médica, Hospital U. Marqués de Valdecilla, Av. Marqués de Valdecilla s/n, 39008 SANTANDER, SPAIN. Email:

Summary

  • Opened in January 2003
  • Accrual completed in May 2004 with 63 patients

Objective

  • To determine the rate of pathological complete response (pCR) after induction treatment with doxorubicin and cyclophosphamide (AC) followed by weekly docetaxel in patients with operable breast cancer (stage II disease).

Scheme

  • AC:Doxorubicin 60 mg/m2plus cyclophosphamide 600 mg/m2day 1 every 3 weeks (4 cycles), followed by
  • T:Docetaxel 36 mg/m2day 1, weekly, for 6 weeks.

A docetaxel cycle is defined as 6-weekly docetaxel infusions followed by 2 weeks without treatment (8 weeks).It is planned to administer 2 docetaxel cycles prior to primary breast surgery.

Update

  • Presented (Poster) at the 29th European Society for Medical Oncology (ESMO) (2004).
  • Presented (Poster) at the 28th Annual San Antonio Breast Cancer Symposium (2005).

Related Publications

None available

Topics

  • Docetaxel
  • Neo-adjuvant treatment

Keywords

Docetaxel, neo-adjuvant treatment

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

Title

A multicenter, open-label, randomized phase III trial comparing six courses of FAC (fluorouracil, doxorubicin, cyclophosphamide) with four courses of FAC followed by 8-weekly administrations of Taxol in the adjuvant treatment of node-negative patients with operable breast cancer. GEICAM/2003–02

Coordinator(s)

M. Martin, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

A. Barnadas, Servicio de Oncología Mádeica, Hospital de Sant Creu i Sant Pau, Avda. Antoni Ma Claret, 167, 08025 BARCELONA, SPAIN.

A. Ruiz, Servicio de Oncología Médica, Instituto Valenciano de Oncología, C/ Professor Beltrán Baguera, 19, 46009 VALENCIA, SPAIN.

Summary

  • Opened in September 2003
  • Target: 1920 patients

Objective

  • To determine the relative efficacy and toxicity of 5-fluorouracil with doxorubicin and cyclophosphamide (FAC) versus 5-fluorouracil with doxorubicin and cyclophosphamide (FAC) followed by weekly paclitaxel as chemotherapy for operable breast cancer patients with negative axillary lymph nodes.

Scheme

Update

  • Accrual: 1100 patients as of March 2006.

Related Publications

None available

Topics

  • Adjuvant treatment
  • Node-negative breast cancer
  • Paclitaxel

Keywords

Adjuvant treatment, node-negative breast cancer, paclitaxel

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Title

A multicenter, open-label, randomized phase III trial comparing epirubicin plus cyclophosphamide (EC) followed by docetaxel (T) with epirubicin plus docetaxel (ET) followed by capecitabine (X) in the adjuvant treatment of node-positive patients with operable breast cancer. GEICAM/2003–10

Coordinator(s)

M. Martin, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, Prof Martín Lagos s/n, 28040 MADRID, SPAIN.

A. Lluch, Servicio de Oncología Médica, Hospital Clínico U. de Valencia, Avda. Blasco Ibañez, 17, 46010 VALENCIA, SPAIN.

Summary

  • Opened in January 2004
  • Target: 1382 patients

Objective

  • To determine the relative efficacy and toxicity epirubicin plus cyclophosphamide (EC) followed by docetaxel (T) with epirubicin plus docetaxel (ET) followed by capecitabine (X) in the adjuvant treatment of node-positive patients with operable breast cancer.

Scheme

Update

Accrual: 975 patients as of March 2006.

Related Publications

None available

Topics

  • Adjuvant treatment
  • Node-positive breast cancer
  • Capecitabine
  • Docetaxel

Keywords

Adjuvant treatment, node-positive breast cancer, capecitabine, docetaxel

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Title

Open-label, no randomized, phases I–II of the treatment with Myocet/Taxotere/Herceptin as primary antineoplasic treatment in newly diagnosed breast cancer patients with HER2neu overexpression. GEICAM/2003–03

Coordinator(s)

A. Antón, Servicio de Oncología Médica, H. Universitario Miguel Servet, Avda. Isabel La Católica, 1 y 3, 50009 ZARAGOZA, SPAIN.

Summary

  • Opened in February 2004
  • Target: 9–24 patients

Objective

  • To assess the maximum tolerated dose of Myocet and Taxotere in combination with Herceptin.

Scheme

Open, single-arm, non-randomized phase I–II escalation trial in 3–6 patients/cohorts:

  • Myocet: 50 mg/m2, every 3 weeks, for 6 cycles.
  • Taxotere: 60 mg/m2, every 3 weeks, for 6 cycles.
  • Herceptin: trastuzumab 4 mg/kg loading dose by i.v. infusion over 90 minutes followed by trastuzumab 2 mg/kg by i.v. infusion over 30 minutes weekly, every 3 weeks, for 6 cycles.

Update

Accrual 19 patients as of March 2006. A phase II study is ongoing to assess efficacy of such a schedule of therapy.

Related Publications

None available

Topics

  • Neo-adjuvant treatment
  • HER2-positive patients
  • Liposomal doxorubicin

Keywords

Neo-adjuvant treatment, HER2-positive patients, liposomal doxorubicin

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Title

Phase IV.II clinical trial with the combination of pegylated liposomal doxorubicin, cyclophosphamide and trastuzumab in patients with metastatic breast cancer with overexpression HER2neu. GEICAM/2004–05

Coordinator(s)

M. Martín, Servicio de Oncología Médica, Hospital Clínico U. San Carlos, Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

Summary

  • Opened in January 2006
  • Target: 49 patients

Objective

  • To evaluate objective response rate.

Scheme

Update

  • Accrual: 1 patient as of March 2006.

Related Publications

None available

Topics

  • Liposomal doxorubicin
  • HER2-positive patients
  • Metastatic breast cancer

Keywords

Liposomal doxorubicin, HER2-positive patients, metastatic breast cancer

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Title

Randomized clinical trial to compare the benefit of adding trastuzumab to the combination of capecitabine plus vinorelbine as second-line treatment for patients with locally advanced non-operable breast cancer or metastatic breast cancer with overexpression of HER2, who have progressed to a previous line of treatment for metastatic disease that included trastuzumab in combination with taxanes. GEICAM/2004–06

Coordinator(s)

M. Muñoz, Servicio de Oncología Médica, Hospital Clinic i Provincial, Villarroel, 170, 08036 BARCELONA, SPAIN.

Summary

  • Opened in January 2006
  • Target: 82 patients

Objective

  • To evaluate objective response rate.

Scheme

Update

  • Accrual: 3 patients as of March 2006.

Related Publications

None available

Topics

  • Metastatic breast cancer
  • HER2-positive patients

Keywords

Metastatic breast cancer, HER2-positive patients

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Title

Phase IV.II clinical trial, multicenter, for administration of capecitabine concomitant to radiotherapy in patients with locally advanced breast cancer and HER2neu negatives. GEICAM/2005–01

Coordinator(s)

M. de las Heras, Servicio de Oncología Radioterápica, Hospital Clínico Univ. San Carlos, C/Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

M. Martín, Servicio de Oncología Médica, Hospital Clínico Univ. San Carlos, C/Professor Martín Lagos s/n, 28040 MADRID, SPAIN.

Summary

  • Initiation of inclusion in July 2006
  • Target: 46 patients

Objective

  • To determine the rate of pathological complete response.

Scheme

Update

None available

Related Publications

None available

Topics

  • Radiotherapy
  • Objective response rate
  • Loco-regional relapse

Keywords

Radiotherapy, objective response rate, loco-regional relapse

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Title

Phase IV.III, multicenter, open, randomized treatment study to evaluate the efficacy of maintenance therapy with capecitabine after standard chemotherapy with anthracyclines in patients with metastatic breast cancer. GEICAM/2005–04

Coordinator(s)

A. Barnadas, Servicio de Oncología Médica, Hospital de Sant Creu i Sant Pau, Avda. Mantoni María Claret, 167, 08025 BARCELONA, SPAIN.

E. Alba, Servicio de Oncología Médica, Hospital Clínico Univ. Virgen de la Victoria, Colonia Santa Inés s/n, Campus Universitario Teatinos, 29010 MÁLAGA, SPAIN.

Summary

  • Initiation of inclusion in May 2006
  • Target: 128 patients

Objective

  • To evaluate time to disease progression after maintenance treatment with capecitabine (Xeloda) in patients with complete or partial response, or stable disease, versus non-maintenance treatment.

Scheme

Update

None available

Related Publications

None available

Topics

  • Metastatic breast cancer
  • Maintenance treatment
  • Capecitabine

Keywords

Metastatic breast cancer, maintenance treatment, capecitabine