Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer
The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with ER negative, PR negative and HER-2 negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer|
- To determine the pathologic complete response rate after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine the clinical response rate, defined as the number of partial and complete responses, after preoperative therapy with cisplatin and bevacizumab in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine the feasibility and toxicity of administering bevacizumab in combination with standard adjuvant chemotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cyclesDrug: bevacizumab
Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxelDrug: doxorubicin
Postoperative: Given intravenously for four 2-week cyclesDrug: cyclophosphamide
Postoperative: Given intravenously for four two-week cyclesDrug: paclitaxel
Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)
- To prepare for surgery, a small "clip" will be placed into the tumor area so that the surgeon can locate the site of the tumor at the time of surgery. This is a standard procedure for breast cancer.
- The study drugs will be given in four 3-week cycles (about 3 months). Participants will come into the clinic each day they receive study treatment intravenously. Cisplatin will be given on day one of the treatment cycle (once every 3 weeks) for four cycles. Bevacizumab will be given on day one of the treatment cycle for three cycles.
- On day one of each 3-week cycle a physical exam, routine blood tests and urine test will be performed. 7-8 days after chemotherapy, blood tests and a hearing test will be performed. A preoperative study visit will take place 7-10 days before surgery and a physical exam, routine blood tests, EKG and an MRI of the breast will be performed.
- Surgery to remove the tumor will occur at least three weeks after the last dose of cisplatin and is considered standard of care.
- Postoperative chemotherapy will begin at least three weeks after surgery. Everyone on the research study will receive four 2-week cycles of doxorubicin and cyclophosphamide plus bevacizumab. After the 8 weeks, the doctor will decide which of the following two treatment regimens the participant will receive: Bevacizumab for four 2-week cycles (once every two weeks) or; Paclitaxel plus bevacizumab for four 2-week cycles (once every two weeks).
- At the end of the postoperative chemotherapy, the participant will return to the clinic for a medical history, physical exam, vital signs, performance status, routine blood tests, MUGA or Echo Scans, and a hearing test.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580333
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Paula D. Ryan, MD||Fox Chase Cancer Center|