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


Phase 2
18 Years
N/A
Not Enrolling
Female
BRCA1 Mutation, Metastatic Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate

Outcome Description:

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

Outcome Time Frame:

Six Months

Safety Issue:

Yes

Principal Investigator

Tomasz Byrski, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pomenarian Medical University

Authority:

Poland: Ministry of Health

Study ID:

BN-001/83/07

NCT ID:

NCT01611727

Start Date:

July 2007

Completion Date:

April 2009

Related Keywords:

  • BRCA1 Mutation
  • Metastatic Breast Cancer
  • BRCA1
  • survival
  • metastatic disease
  • cisplatin
  • Breast Neoplasms

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