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

NCT01611727 | Completed Phase 2

• 1 other identifier: BN-001/83/07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

BRCA1 Mutation; Metastatic Breast Cancer

Keywords

BRCA1; survival; metastatic disease; cisplatin

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate

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

  Six Months

Study Arms (1)

Cisplatin

EXPERIMENTAL

Drug: Cisplatin

Interventions

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.

Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• Maria Sklodowska-Curie National Research Institute of Oncology: collaborator

Study Sites (1)

Pomenarian Medical University

Szczecin, Poland

Location

Related Publications (1)

• Byrski T, Dent R, Blecharz P, Foszczynska-Kloda M, Gronwald J, Huzarski T, Cybulski C, Marczyk E, Chrzan R, Eisen A, Lubinski J, Narod SA. Results of a phase II open-label, non-randomized trial of cisplatin chemotherapy in patients with BRCA1-positive metastatic breast cancer. Breast Cancer Res. 2012 Jul 20;14(4):R110. doi: 10.1186/bcr3231.

  PMID: 22817698 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Tomasz Byrski, MD, PhD

  Pomenarian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

PL (1)