Clinical trial NCT01611727: Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients
Official title: Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: BRCA1 Mutation
Metastatic Breast Cancer
Keywords: BRCA1
survival
metastatic disease
cisplatin
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
Collaborators: name: Maria Sklodowska-Curie National Research Institute of Oncology
First posted: 2012-06-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Tumor Response Rate
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomenarian Medical University
Study officials:
affiliation: Pomenarian Medical University
name: Tomasz Byrski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.