Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00203372|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Bevacizumab 7.5 and TAC Drug: Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) Drug: Bevacizumab 15 and TAC Drug: Placebo 15 and TAC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||June 2012|
Experimental: Bevacizumab 7.5 and TAC
one dose of Bevacizumab (7.5mg/kg) will be administered intravenously every 3 weeks followed by TAC.
Drug: Bevacizumab 7.5 and TAC
Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).
Placebo Comparator: Placebo 7.5 and TAC
Placebo7.5 will be administered intravenously every 3 weeks followed by TAC.
Drug: Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)
placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC
Experimental: Bevacizumab 15 and TAC
one dose of Bevacizumab (15mg/kg) will be administered intravenously every 3 weeks followed by TAC.
Drug: Bevacizumab 15 and TAC
one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.
Placebo Comparator: Placebo 15 and TAC
Placebo 15mg/kg will be administered intravenously every 3 weeks followed by TAC.
Drug: Placebo 15 and TAC
one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.
- •To evaluate the safety and toxicity of the TAC regimen with the addition of bevacizumab given as preoperative therapy to patients with Stage II or Stage III breast cancer [ Time Frame: 4 years ]Patients will be evaluated for adverse events (all grades) at each study visit for the duration of their participation in the study. All AEs should be graded using the NCI--CTCAE, Version 3.0. Patients discontinued from the treatment phase of the study for any reason will be evaluated within 30 days after the decision to discontinue treatment.
- •To estimate change from baseline expression of HIF1α as a measure of tumor angiogenesis, after a single dose of bevacizumab as compared to placebo [ Time Frame: 4 years ]
- •To estimate the rate of CHF in patients receiving TAC with or without bevacizumab [ Time Frame: 4 years ]
- •To estimate the rates of left ventricular ejection fraction (LVEF) changes as measured by either a decrease of > 15% from baseline, or > 10% to a value below the lower limit of normal (for the institution), in patients receiving TAC or TAC + bevacizumab [ Time Frame: 4 years ]
- •To investigate the clinical efficacy of TAC and TAC plus bevacizumab by estimating the clinical objective response rate (CR + PR), pathologic complete response rate (pCR), and rate of breast-conserving surgery (BCS) [ Time Frame: 4 years ]
- •To estimate the rate of post-surgical wound healing complications in patients who receive surgery after TAC or TAC plus bevacizumab [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203372
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|Wilshire Oncology Medical Group, Inc.|
|Pomona, California, United States, 91767|
|United States, Florida|
|Cancer Institute of Florida, P.A.|
|Orlando, Florida, United States, 32804|
|United States, Georgia|
|Northwest Georgia Oncology Centers, P.C.|
|Marietta, Georgia, United States, 30060|
|United States, Texas|
|South Texas Oncology and Hematology, P.A.|
|San Antonio, Texas, United States, 78207|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Montreal, Quebec, Canada, H2W 1S6|
|St. Vincent's University Hospital|
|Dublin, Ireland, 4|
|St. James's Hospital|
|Dublin, Ireland, 8|
|Study Chair:||Fairooz Kabbinavar, MD||Chief Medical Officer|