Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Pomeranian Medical University Szczecin
Collaborators:
Maria Sklodowska-Curie Institute - Oncology Center Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology