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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01611727
Other study ID # BN-001/83/07
Secondary ID
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


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
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