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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Pomeranian Medical University Szczecin.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Regional Oncology Hospital, Bielsko-Biala, Poland
Information provided by (Responsible Party):
Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier:
NCT01630226
First received: June 26, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
BRCA1 Mutation
Breast Cancer Invasive Nos
Drug: Neoadjuvant Cisplatin Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland

Resource links provided by NLM:


Further study details as provided by Pomeranian Medical University Szczecin:

Primary Outcome Measures:
  • Pathologic Complete Response [ Time Frame: Four Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630226

Contacts
Contact: Tomasz Byrski, MD, PhD 48-501-225-501 tomekbyr@wp.pl

Locations
Poland
Pomenarian Medical University Recruiting
Szczecin, Poland
Contact: Tomasz Byrski, MD, PhD    48-501-225-501    tomekbyr@wp.pl   
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Regional Oncology Hospital, Bielsko-Biala, Poland
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: NCT01630226     History of Changes
Other Study ID Numbers: BN-001/83/07-B
Study First Received: June 26, 2012
Last Updated: July 10, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Pomeranian Medical University Szczecin:
BRCA1
pathological complete response
neoadjuvant chemotherapy

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

ClinicalTrials.gov processed this record on September 16, 2014