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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborators: |
Genentech US Oncology Research |
| Information provided by (Responsible Party): | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00887536 |
Purpose
The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: bevacizumab Drug: docetaxel Drug: doxorubicin Drug: cyclophosphamide Drug: pegfilgrastim |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer |
| Estimated Enrollment: | 3900 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | January 2022 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
docetaxel, doxorubicin, cyclophosphomide, and pegfilgrastim/filgrastim
|
Drug: docetaxel
docetaxel 75 mg/m2 IV every 21 days for 6 cycles
Drug: doxorubicin
doxorubicin 50 mg/m2 IV every 21 days for 6 cycles
Drug: cyclophosphamide
cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Drug: pegfilgrastim
pegfilgrastim 6 mg SC Day 2 every 21 days for 6 cycles [filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.]
|
|
Active Comparator: Group 2
docetaxel and cyclophosphamide
|
Drug: docetaxel
docetaxel 75 mg/m2 IV every 21 days for 6 cycles
Drug: cyclophosphamide
cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles
|
|
Experimental: Group 3
docetaxel, cyclophosphamide, and bevacizumab
|
Drug: bevacizumab
bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab
Drug: docetaxel
docetaxel 75 mg/m2 IV every 21 days for 6 cycles
Drug: cyclophosphamide
cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles
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The B-46-I/07132 study, a multicenter, open-label, randomized Phase III, adjuvant therapy trial, will compare the value of adding bevacizumab to a non-anthracycline-based chemotherapy regimen relative to the same chemotherapy without bevacizumab and relative to an anthracycline-based chemotherapy regimen in women with resected node-positive or high-risk node-negative, HER2-negative breast cancer. This trial will determine whether the addition of bevacizumab to a regimen of docetaxel and cyclophosphamide (TCB) improves invasive disease-free survival relative to docetaxel and cyclophosphamide alone (TC). A secondary aim will be to determine whether the addition of bevacizumab to TC improves invasive disease-free survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC). Other secondary aims include whether TCB improves disease-free survival, overall survival, and recurrence-free interval relative to TC alone and to TAC. The toxicities of the three regimens will also be compared.
Patients in the B-46-I/07132 study will be randomized to one of three treatment regimens: Group 1 patients will receive 6 cycles of TAC administered every 21 days (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); Group 2 patients will receive 6 cycles of TC administered every 21 days (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2); and Group 3 patients will receive 6 cycles of TCB every 21 days with bevacizumab therapy continuing every 21 days after completion of chemotherapy until 1 year following the first dose (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2, and bevacizumab 15 mg/kg). Primary prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients (optional for patients in Groups 2 and 3). Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors.
Tumor samples will be submitted for correlative science studies to evaluate predictors of study therapy benefit. Submission of a tumor sample is a study requirement for all patients.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 533 Study Locations| Principal Investigator: | Norman Wolmark, MD | NSABP Foundation, Inc. |
More Information
| Responsible Party: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00887536 History of Changes |
| Other Study ID Numbers: | NSABP B-46-I, USOR 07132 |
| Study First Received: | April 23, 2009 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Ireland: Irish Medicines Board Ireland: Research Ethics Committee |
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NSABP Taxotere Docetaxel Doxorubicin Cyclophosphamide Bevacizumab Breast Neoplasms |
Adenocarcinoma Breast Diseases Carcinoma HER2 negative Node negative High risk node positive Adjuvant Therapy |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Bevacizumab Doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |