Conditions: Metastatic Breast Cancer Breast Cancer Progressive Breast Cancer
Keywords: carboplatin bevacizumab
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief summary:
The purpose of this research study is to determine how well the combination of bevacizumab and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body) that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Usually chemotherapy drugs attack fast growing cancer cells in the body. Bevacizumab works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to the tumors. When the blood supply is decreased, the tumors don't get the oxygen and nutrients they need to grow. Carboplatin is in a class of drugs known as platinum-containing compounds and has been approved for use in the treatment of ovarian cancer. Information from other research studies suggests that the combination of bevacizumab with carboplatin may be effective in treating breast cancer.

Detailed description:
This study used a two-stage design to evaluate efficacy bevacizumab and carboplatin based on Central Nervous System (CNS) response. The null and alternative therapy response rates are 5% versus 20%. If 1 or more participants assessable in the stage one cohort (n=12 assessable participants) achieve CNS response then accrual proceeds to stage two (n=25 additional assessable participants). If at least 4 participants in the final set of 37 assessable participants achieve CNS response then this regimen would be deemed worthy of further study. The probability of stopping early is 0.54 if the true CNS response rate is 5% and 0.07 if the true CNS response rate is 20%. The probability of deeming the treatment worthy of further study is 0.10 and 0.90 if the true CNS response rate is 5% and 20%, respectively.

Arms:
arm 1: Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.

carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle

bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle

trastuzumab\*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only

\*8mg/kg loading dose in cycle 1 for some participants

HER-2: human epidermal growth factor receptor 2

Interventions: intervention 1: carboplatin intervention 2: bevacizumab intervention 3: herceptin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: