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

Phase 2

Completed

• Conditions: BRCA1 Mutation; Metastatic Breast Cancer
• Interventions: Drug: Cisplatin

• Registration Number: NCT01611727
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate	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.

Trial Locations

Locations (1)

Pomenarian Medical University; 🇵🇱 Szczecin, Poland