Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Pomeranian Medical University Szczecin
Collaborators:
Maria Sklodowska-Curie Institute - Oncology Center Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology Regional Oncology Hospital, Bielsko-Biala, Poland