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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00408408 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Biological: bevacizumab Drug: capecitabine Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens |
Estimated Enrollment: | 1200 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC comprising doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses. Patients then undergo surgery (lumpectomy or mastectomy). |
Biological: bevacizumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo surgery
|
Arm II: Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel as in Arm I. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC as in Arm I and 2 additional courses of bevacizumab concurrent with the first 2 courses of AC. Patients then undergo surgery as in Arm I. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
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Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo surgery
|
Arm III: Experimental
Patients receive docetaxel as in Arm I and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I.
|
Drug: capecitabine
Given orally
Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo surgery
|
Arm IV: Experimental
Patients receive bevacizumab as in Arm II and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive bevacizumab IV over 30 minutes on day 1 and AC as in Arm I. Treatment repeats every 3 weeks for up to 4 courses (2 courses of bevacizumab). Patients then undergo surgery as in Arm I. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm II.
|
Biological: bevacizumab
Given IV
Drug: capecitabine
Given orally
Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo surgery
|
Arm V: Experimental
Patients receive docetaxel as in Arm I and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I.
|
Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: gemcitabine hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo surgery
|
Arm VI: Experimental
Patients receive docetaxel as in Arm I, gemcitabine hydrochloride as in Arm V, and bevacizumab as in Arm II. Patients then receive AC with bevacizumab as in Arm II. Patients then undergo surgery as in Arm I. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm II.
|
Biological: bevacizumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: gemcitabine hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo surgery
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive adenocarcinoma of the breast
No ipsilateral cN2b or cN3 disease
No prior surgical axillary staging procedure
No prior breast cancer, including DCIS
PATIENT CHARACTERISTICS:
AST ≤ 1.5 times ULN
No cardiovascular-related condition that would preclude the use of anthracyclines, including any of the following:
Uncontrolled hypertension, defined as blood pressure > 150/90 mm Hg on antihypertensive therapy
No known bleeding diathesis or coagulopathy
PRIOR CONCURRENT THERAPY:
No major surgical procedure or open biopsy within the past 28 days
Study Chair: | Harry D. Bear, MD, PhD | Massey Cancer Center |
Responsible Party: | National Surgical Adjuvant Breast and Bowel Project ( Norman Wolmark ) |
Study ID Numbers: | CDR0000515432, NSABP-B-40 |
Study First Received: | December 6, 2006 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00408408 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Antimetabolites Capecitabine Skin Diseases Immunologic Factors Breast Neoplasms Cyclophosphamide Bevacizumab Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents |
Doxorubicin Docetaxel Anti-Bacterial Agents Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Gemcitabine Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Cyclophosphamide Antibiotics, Antineoplastic Docetaxel Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Gemcitabine Alkylating Agents Breast Diseases Capecitabine Skin Diseases Growth Substances Breast Neoplasms Enzyme Inhibitors Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents |