A Phase II Study of Preoperative Dose-dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel (T) With Bevacizumab in ER+ and/or PR+, HER2-negative Operable Breast Cancer
- To prepare for the surgery that will occur at the end of the study treatment, 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.
- During the clip placement, a needle will be inserted into the tumor to measure
interstitial fluid pressure (IFP measurement). IFP is done for research purposes to
help understand how the tumor responds to the study treatment.
- Study treatment will begin with one dose of bevacizumab alone, followed two weeks later
by chemotherapy and bevacizumab in eight two-week cycles. The study treatment will be
given intravenously in the clinic.
- After the first dose of bevacizumab and prior to starting chemotherapy, a needle biopsy
of the breast tumor will be performed for research purposes. A second measurement of
IFP will also be done at this time.
- During the treatment period, tests and procedures will be performed at specified
intervals and include the following: research MRI, physical exams, blood tests, urine
tests, EKG, and MUGA or ECHO.
- Surgery to remove the tumor will occur no less than four weeks after the last dose of
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.
Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery
Ian Krop, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|New Hampshire Oncology-Hematology PA||Hooksett, New Hampshire 03106|
|Dana-Farber at Faulkner Hospital||Boston, Massachusetts 02130|