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

Metastatic Breast Cancer Clinical Trial

— Cisplatin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611727
• Other study ID #: BN-001/83/07
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2012
• Last updated: July 10, 2012
• Start date: July 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2012
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Cisplatin
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.

Locations

Country	Name	City	State
Poland	Pomenarian Medical University	Szczecin

Sponsors (2)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes