Breast Cancer Clinical Trial
Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed invasive breast cancer, with metastatic disease. patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis by physical exam or radiologic study
Measurable disease. Patients must have measurable CNS disease, defined as at least one parenchymal brain lesion that can be accurately measured in at least one dimension with longest dimension >/= 10mm by local radiology review
New or progressive CNS lesions, as assessed by the patient's treating physician
No increase in corticosteroid dose in the week prior to the baseline brain MRI
18 years of age or older
Life expectancy of greater than 12 weeks
Eastern Cooperative Oncology Group Performance Score (ECOG PS) performance status 0-2
Normal organ and marrow function as outlined in the protocol
Left ventricular ejection fraction >/= 50%, as determined by radionuclide ventriculography (RVG) or echocardiogram within 60 days prior to initiation of protocol therapy
Prior carboplatin is allowed if it was not given in conjunction with bevacizumab
Prior trastuzumab is allowed
No prior bevacizumab since diagnosis of CNS metastases or within 6 months prior to diagnosis of CNS metastases
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria:
Patients who have had chemotherapy within 14 days prior to entering the study, or those who have not recovered adequately from adverse events due to agents administered earlier
Patients may not receive any concurrent investigational agents while on study
Patients may not receive any cancer-directed concurrent therapy , such as concurrent chemotherapy, radiotherapy, or hormonal therapy while on study. Concurrent treatment with bisphosphonates is allowed
History of Grade 3 or 4 allergic reactions attributed to compounds of similar or identical biologic composition to bevacizumab, carboplatin, or trastuzumab
Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body
Leptomeningeal carcinomatosis as the only site of CNS involvement
More than 2 seizures over last 4 weeks prior to study entry
Grade 1 or higher CNS hemorrhage on baseline brain MRI
History of grade 2 or higher CNS hemorrhage within 12 months of study entry
Inadequately controlled hypertension
Prior history of hypertensive crisis or hypertensive encephalopathy
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infraction or unstable angina within 6 months prior to day 1
Significant vascular disease within 6 months prior to day 1
History of hemoptysis within 1 month prior to day 1
Evidence of bleeding diathesis or significant coagulopathy
Current, ongoing treatment with full-dose warfarin or its equivalent
Use of aspirin (>325 mg/day) within 10 days prior to day 1
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 or anticipation of need for major surgical procedure during the course of the study.
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to day 1
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1
Serious, non-healing wound, active ulcer, or untreated bone fracture
Proteinuria as demonstrated by a urine protein-creatinine ratio >/= 1.0 at screening
Known hypersensitivity to any component of bevacizumab
Pregnancy or lactation
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There are 3 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
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