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

This study has been completed.
Sponsor:
Collaborator:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Information provided by (Responsible Party):
Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier:
NCT01611727
First received: May 31, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
BRCA1 Mutation
Metastatic Breast Cancer
 Drug: Cisplatin
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Pomeranian Medical University Szczecin:

Primary Outcome Measures:
  • Tumor Response Rate [ Time Frame: Six Months ] [ Designated as safety issue: Yes ]
    This is defined as the percentage of patients who achieved a complete response or partial response by RECIST criteria within the first six months.


Enrollment: 20
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611727

Locations
Poland
Pomenarian Medical University
Szczecin, Poland
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Investigators
Principal Investigator: Tomasz Byrski, MD, PhD Pomenarian Medical University
  More Information

No publications provided

Responsible Party: Tomasz Byrski, MD, PhD, MD, PhD, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT01611727     History of Changes
Other Study ID Numbers: BN-001/83/07
Study First Received: May 31, 2012
Last Updated: July 10, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Pomeranian Medical University Szczecin:
BRCA1
survival
metastatic disease
cisplatin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013