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Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland

Phase 2
20 Years
70 Years
Open (Enrolling)
BRCA1 Mutation, Breast Cancer Invasive Nos

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Trial Information

Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrolment
into the trial:

1. Histologically or cytologically proven diagnosis of invasive breast cancer (stage

2. Documentation of the presence of a germ-line BRCA1 mutation

3. Measurable disease of any size by mammography or ultrasound.

4. Female diagnosed with breast cancer between the ages of 20 to 70.

5. Eastern Cooperative Oncology Group [ECOG] performance status of 0 and 1.

6. Evidence of adequate organ function (liver, bone marrow, kidney)

7. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrolment.

8. Willingness and ability to comply with scheduled visits, treatment plans laboratory
tests, and other study procedures.

9. Polish resident.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the trial:

1. Previous chemotherapy for current cancer.

2. Previous or current diagnosis of any other malignancy except for adequately treated
basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.

3. Receiving any medication that may markedly affect renal function.

4. Pregnant or breastfeeding women.

5. Uncontrolled inter-current illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness that would limit compliance with study

Type of Study:


Study Design:

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

Outcome Measure:

Pathologic Complete Response

Outcome Time Frame:

Four Months

Safety Issue:


Principal Investigator

Tomasz Byrski, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pomenarian Medical University


Poland: Ministry of Health

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • BRCA1 Mutation
  • Breast Cancer Invasive Nos
  • BRCA1
  • pathological complete response
  • neoadjuvant chemotherapy
  • Breast Neoplasms