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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01611727
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : July 12, 2012
Maria Sklodowska-Curie National Research Institute of Oncology
Information provided by (Responsible Party):
Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin

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.

Condition or disease Intervention/treatment Phase
BRCA1 Mutation Metastatic Breast Cancer Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Cisplatin

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01611727

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Pomenarian Medical University
Szczecin, Poland
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Maria Sklodowska-Curie National Research Institute of Oncology
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Principal Investigator: Tomasz Byrski, MD, PhD Pomenarian Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tomasz Byrski, MD, PhD, MD, PhD, Pomeranian Medical University Szczecin Identifier: NCT01611727    
Other Study ID Numbers: BN-001/83/07
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012
Keywords provided by Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin:
metastatic disease
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents