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

July 10, 2012 updated by: Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin

This is a single center, non-randomized, open label phase II trial to evaluate the clinical and pathologic response of neoadjuvant cisplatin-monotherapy in BRCA1 positive patients. The study will enroll patients with diagnosed breast cancer with a BRCA1 mutation. Patients will be eligible if they have primary breast cancer (measured on mammogram and ultrasound or MRI) and confirmed histological diagnosis of invasive breast cancer by core biopsy. If axilla lymph nodes will be suspected then fine needle aspiration biopsy will be performed. Patients will be drawn from one of three oncology centers: Szczecin, Bielsko-Biała and Kraków.

Patients will obtain staging investigations and will be monitored. Once entry criteria is met and consent obtained, all patients will obtain baseline staging investigation within 3 weeks of trial registration. Routine investigations will include staging scans: mammography, ultrasound of the breast and axilla (assessment of breast tumor and axilla lymph nodes), assessment of chest/abdomen/pelvis (plain film, Computed Tomography [CT] and/or ultrasound as per local standards) and baseline blood work (Complete Blood Count [CBC], electrolytes, creatinine, Liver Function Tests [LFTs], calcium, albumin).

Once staging investigations are complete, all patients will be treated with cisplatin chemotherapy at a dose of 75mg/m2 every three weeks for a total of four cycles (4 cycles of neoadjuvant chemotherapy). Clinical response will be evaluated every three weeks by the treating physician while on chemotherapy (tumour of the breast and axilla lymph nodes). After four cycles of chemotherapy the patient will then undergo definitive surgery (mastectomy or breast-conserving surgery). Sentinel lymph nodes procedure will be performed. In case of positive lymph nodes standard lymph nodes surgery will be performed. Pathological complete response will defined as no evidence of residual tumor in the breast and the axilla. There may be evidence of ductal carcinoma in situ. The pathology will reviewed by two independent pathologists.

Following surgery patients will receive standard adjuvant chemotherapy at the discretion of the treating physician and if indicated, the patient will also receive radiotherapy and/or hormonal therapy and/or adjuvant trastuzumab at the description of the treating physician.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tomasz Byrski, MD, PhD
  • Phone Number: 48-501-225-501
  • Email: tomekbyr@wp.pl

Study Locations

  • Poland
      • Szczecin, Poland
        • Recruiting
        • Pomenarian Medical University
        • Contact:
          • Tomasz Byrski, MD, PhD
          • Phone Number: 48-501-225-501
          • Email: tomekbyr@wp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 I-III).
  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 requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant Cisplatin Chemotherapy
Drug: Neoadjuvant Cisplatin Chemotherapy
Patients will be treated with cisplatin chemotherapy at a dose of 75mg/m2 every three weeks for a total of four cycles (4 cycles of neoadjuvant chemotherapy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response
Time Frame: Four Months
Four Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Collaborators

Maria Sklodowska-Curie National Research Institute of Oncology
Regional Oncology Hospital, Bielsko-Biala, Poland

Investigators

  • Principal Investigator: Tomasz Byrski, MD, PhD, Pomenarian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BN-001/83/07-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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