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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) Genentech Hoffmann-La Roche IDDI |
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Information provided by: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
ClinicalTrials.gov Identifier: | NCT00365417 |
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Bevacizumab Drug: Doxorubicin Drug: Cyclophosphamide Drug: Capecitabine Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Clinical Trial of Bevacizumab Beginning Concurrently With a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women With Locally Advanced Breast Cancer |
Enrollment: | 45 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Bevacizumab
15 mg/kg IV every 21 days x 4 cycles, then after clinical response asssesment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles
Drug: Doxorubicin
60 mg/m2 IV every 21 days x 4 cycles
Drug: Cyclophosphamide
600 mg/m2 IV every 21 days x 4 cycles
Drug: Capecitabine
Following clinical response assesment, 650 mg/m2 twice a day (orally), days 1-14 every 21 days x 4 cycles
Drug: Docetaxel
Following clincial response assesment, 75 mg/m2 IV every 21 days x 4 cycles
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Initial trials of neoadjuvant chemotherapy administered for locally advanced tumors, including those in breast cancer, demonstrated therapy could induce sufficient tumor regression to allow for the resection of otherwise unresectable tumors. Subsequent demonstration of the equivalence of lumpectomy to mastectomy in patients with operable breast cancer, stimulated interest in the concept of using preoperative chemotherapy to reduce large, but operable, primary tumors to allow for lumpectomy in women who would otherwise require a mastectomy. Given the data from previous studies, it is appropriate to continue development of sequential doxorubicin/cyclophosphamide/docetaxel regimens to improve on clinical and pathologic response rates. FB-4 is a Phase II, single arm study for women with locally advanced HER2-negative breast cancer diagnosed by core needle biopsy. The primary aim of the study is to determine the pathologic complete response rate in the breast following neoadjuvant chemotherapy combined with bevacizumab.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At the time of study entry, blood counts must meet the following criteria:
The following criteria for evidence of adequate hepatic function must be met:
The following criteria for evidence of adequate renal function must be met:
Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued following AC and postoperatively, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the MUGA scan or echocardiogram must be repeated prior to study entry. The lower of the two LVEF values should be used as the baseline LVEF.
Exclusion Criteria:
History of any of the following cancers:
Any of the following cardiac conditions:
Invasive procedures defined as follows:
United States, Pennsylvania | |
NSABP Foundation, Inc. | |
Pittsburgh, Pennsylvania, United States, 15212 |
Principal Investigator: | Norman Wolmark, MD | NSABP Foundation, Inc. |
Responsible Party: | NSABP Foundation, Inc. ( Norman Wolmark, MD ) |
Study ID Numbers: | NSABP FB-4 |
Study First Received: | August 15, 2006 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00365417 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee |
NSABP Doxorubicin Cyclophosphamide Bevacizumab Capecitabine |
Docetaxel Breast cancer Locally advanced Neoadjuvant Locally advanced breast cancer |
Docetaxel Capecitabine Skin Diseases Breast Neoplasms |
Bevacizumab Cyclophosphamide Doxorubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antibiotics, Antineoplastic Angiogenesis Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |