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.

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Key information

Conditions

BRCA1 Mutation Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pomenarian Medical University

Szczecin, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients aged ≥ 18 years, with measurable (defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14)) metastatic (stage IV) breast cancer, and who are known to carry a BRCA1 mutation, are eligible.
In addition, the following are required:

adequate hematologic
renal, and hepatic function
adequate recovery from recent surgery and/or radiation therapy
recovery from all prior treatment-related toxicities (to grade < 2 according to National Cancer Institute Common Toxicity Criteria, Version3.0, except alopecia)
life expectancy of at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. -
Patients could have received up to four prior chemotherapies for metastatic disease.

Exclusion criteria

Patients with known brain metastases are not eligible.
Patients previously treated with a platinum-based chemotherapy are not eligible.

Treatment and study plan

Cisplatin

Drug

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.

Primary outcomes

Tumor Response Rate

Time frame: Six Months

This is defined as the percentage of patients who achieved a complete response or partial response by RECIST criteria within the first six months.

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Collaborators

Maria Sklodowska-Curie National Research Institute of Oncology

Registry information

Official study title

Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer

Acronym: Cisplatin

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jun 5, 2012
Registry last updated: Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed