Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients
Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage.
It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer|
- Tumor Response Rate [ Time Frame: Six Months ] [ Designated as safety issue: Yes ]This is defined as the percentage of patients who achieved a complete response or partial response by RECIST criteria within the first six months.
|Study Start Date:||July 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Cisplatin chemotherapy will be administered as a 75 mg/m2 intravenous (IV) infusion every 3 weeks, for six cycles. Dexamethasone (8mg) will be administered once daily for three days after chemotherapy. Ondansetron (Zofran™) will be used for anti-nausea prophylaxis.
|Pomenarian Medical University|
|Principal Investigator:||Tomasz Byrski, MD, PhD||Pomenarian Medical University|