BREAST – Contact Details
Country
Europe, Africa, South America, Middle East
Chair
M.J. Piccart, Jules Bordet Institute, Medical Oncology Clinic, Rue Héger-Bordet 1, B-1000 BRUSSELS, BELGIUM. Tel: +32 2 541 3206 Fax: +32 2 538 0858 Email: [email protected]
Data Center
Jules Bordet Institute, BREAST Operational Office, Boulevard de Waterloo 121, B-1000 BRUSSELS, BELGIUM. Tel: +32 2 541 3181 Fax: +32 2 541 3090 Email: [email protected]
Website
BREAST – Study Details
Title
An intergroup phase III trial to evaluate the activity of docetaxel, given either sequentially or in combination with doxorubicin, followed by CMF, in comparison to doxorubicin alone or in combination with cyclophos-phamide, followed by CMF, in the adjuvant treatment of node-positive breast cancer patients. BIG 02-98/TAX 315
Coordinator(s)
C. Bernard, Jules Bordet Institute, BREAST Operational Office, Rue Héger Bordet 1, B-1000 BRUSSELS, BELGIUM. Tel: +32 2 541 3180 Fax: +32 2 541 3090 Email: [email protected]
M.J. Piccart, Jules Bordet Institute, Medical Oncology Clinic, Rue Héger Bordet 1, B-1000 BRUSSELS, BELGIUM. Tel: +32 2 541 3206 Fax: +32 2 538 0858 Email: [email protected]
J. Crown, St Vincent's Hospital, Elm Park, DUBLIN 4, IRELAND. Tel: +353 1 209 4895 Fax: +353 1 283 7719 Email: [email protected]
P. Francis, Peter MacCallum Cancer Institute, St Andrews Place, 3002 East Melbourne, VIC, AUSTRALIA. Tel: +61 3 9656 1700 Fax: +61 3 9656 1408 Email: [email protected]
Summary
- Opened in June 1998
- Target accrual: 2730 patients
Primary Objectives
- To compare disease-free survival of an adjuvant treatment with dox-orubicin followed by docetaxel, followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes.
- To compare disease-free survival of an adjuvant treatment with doc-etaxel in combination with doxorubicin followed by CMF to doxoru-bicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes.
Secondary Objectives
- To compare disease-free survival of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes.
- To compare disease-free survival of an adjuvant treatment with dox-orubicin followed by docetaxel, followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes (sequential mono-chemotherapy versus polychemotherapy).
- To compare overall survival of treatment arms.
- To compare toxicity of treatment arms.
- To evaluate pathologic and molecular markers for predicting efficacy.
- Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
Scheme
Radiotherapy
Radiotherapy mandatory in case of breast-conservative surgery;allowed in case of mastectomy, according to the policy in use at each participating center.
Update
- Trial closed 26 June 2001.
- Total patients randomized: 2890.
Related Publications
None available
Topics
- Taxanes
- Node-positive breast cancer
- Anthracyclines
Keywords
None available
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Title
HERA: A randomized three-arm multi-centre comparison of 1 year and 2 years of Herceptin versus no Herceptin in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy. BIG 01-01/B016348
Coordinator(s)
M.J. Piccart, Jules Bordet Institute, Medical Oncology Clinic, Rue Hélger-Bordet 1, B-1000 BRUSSELS, BELGIUM. Tel: +32 2 541 3206 Fax: +32 2 538 0858. Email: [email protected]
Summary
Primary Objectives
- To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin for 1 year versus no Herceptin.
- To compare DFS in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin for 2 years versus no Herceptin.
Secondary Objectives
- To compare overall survival (OS) in patients randomized to: (i) Herceptin for 1 year or no further therapy and (ii) Herceptin for 2 years or no further therapy.
- To compare relapse-free survival (RFS).
- To compare distant disease-free survival (DDFS).
- To evaluate the safety and tolerability of Herceptin.
- To compare the incidence of cardiac dysfunction in patients treated and not treated with Herceptin.
- To compare outcomes (DFS, OS, RFS, DDFS, cardiac safety, overall safety) of patients treated with Herceptin for 1 year compared with Herceptin for 2 years.
Scheme
Primary management pre-HERA (Surgery, [neo-]adjuvant chemotherapy + adjuvant radiotherapy)
Update
- Trial closed 20 June 2005.
- Total number of patients randomized is 5102
Related Publications
Martine J. Piccart-Gebhart et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. New Eng J Med 2005; 353: 1659–1672.
Topics
- HER2 positive patients
- Hormone receptor negative breast cancer
- Hormone receptor positive breast cancer
- Node negative breast cancer
- Node positive breast cancer
- Trastuzumab
Keywords
None available
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Title
BIG2-06/N063D: Phase III Trial of Trastuzumab and/or Lapatinib in Patients with HER2+ Breast Cancer (Full title/acronym not available at time of publication).
Principal Investigators
M.J. Piccart, Jules Bordet Institute, Medical Oncology Clinic, Rue Héger-Bordet 1, B-1000 BRUSSELS, BELGIUM. Tel: +32 2 541 3206 Fax: +32 2 538 0858 Email: [email protected]
E.A. Perez, North Central Cancer Treatment Group, Mayo Clinic, 4600 San Pablo Rd, Jacksonville, FL 32224, Tel: +1 507 284 1159, Email: [email protected]
Summary
Primary Objectives
- To compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for 1 year versus lapatinib for 1 year versus a sequence of trastuzumab and lapatinib (1 year total) versus a combination of trastuzumab and lapatinib (1 year total).
Secondary Objectives
- To compare overall survival (OS) in patients randomized to the four arms.
- To compare time to recurrence (TTR).
- To compare time to distant recurrence (TTDR).
- To evaluate the safety and tolerability of all four treatment groups.
- To compare the cumulative incidence of brain metastases as the first site of breast cancer recurrence.
Target accrual: n = 8000
Scheme
Update
- Trial will open for accrual beginning of 2007.
Related Publications
None available
Topics
- HER2 positive patients
- Hormone receptor negative breast cancer
- Hormone receptor positive breast cancer
- Node negative breast cancer
- Node positive breast cancer
- Trastuzumab
Keywords
Phase III, adjuvant breast cancer, HER2+, trastuzumab, lapatinib, herceptin, tykerb
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Title
Phase III Neo-adjuvant trial of lapatinib, trastuzumab and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer (exact title/acronym not available at time of publication) BIG 1-06
Principal Investigators
J. Baselga, Medical Oncology Service, Vall d'Hebron University Hospital, Passeig Vall d'Hebron 119–129, 08035 BARCELONA, SPAIN, Tel: +34 93 274 6085, Fax: +34 93 274 6026. Email: [email protected]
Summary
Primary Objectives
- To evaluate and compare the rate of pCR at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomized to lapatinib followed by lapatinib plus paclitaxel versus tratsuzumab followed by trastuzumab and paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab and paclitaxel
Secondary Objectives:
- To compare the safety and tolerability of the three treatment arms;
- To compare the objective response rate (complete plus partial responses) among the three treatment arms;
- To compare the percent of patients with node-negative disease at surgery among the three treatment arms;
- To compare the rate of conversion to breast conserving surgery among the three treatment arms;
- To compare disease free (DFS) and overall survival (OS);
- To identify the molecular characteristics of responding tumors by immunohistochemical, FISH, genomic and proteomic analysis;
- To study biomarkers expression before and during therapy and establish correlations with clinical outcome;
- To establish associations between PET/CT and tumor response.
Scheme
Update
- n = 450; trial will open for accrual at the beginning of 2007.
Related Publications:
None available
Topics
- HER2 positive patients, trastuzumab
Keywords
Phase III, neo-adjuvant, HER2+, trastuzumab, lapatinib, herceptin, tykerb, paclitaxel
