A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the pathologic complete response rate after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.
Paula D. Ryan, MD
Fox Chase Cancer Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|