Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland
|ClinicalTrials.gov Identifier: NCT01630226|
Recruitment Status : Unknown
Verified July 2012 by Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin.
Recruitment status was: Recruiting
First Posted : June 28, 2012
Last Update Posted : July 12, 2012
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 or disease||Intervention/treatment||Phase|
|BRCA1 Mutation Breast Cancer Invasive Nos||Drug: Neoadjuvant Cisplatin Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||December 2013|
|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).
- Pathologic Complete Response [ Time Frame: Four Months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630226
|Contact: Tomasz Byrski, MD, PhDfirstname.lastname@example.org|
|Pomenarian Medical University||Recruiting|
|Contact: Tomasz Byrski, MD, PhD 48-501-225-501 email@example.com|
|Principal Investigator:||Tomasz Byrski, MD, PhD||Pomenarian Medical University|