Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01630226
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2012-06-26
Brief Title:
Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 chestabdomenpelvis plain film Computed Tomography CT andor 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 75mgm2 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 andor hormonal therapy andor adjuvant trastuzumab at the description of the treating physician
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 chestabdomenpelvis plain film Computed Tomography CT andor 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 75mgm2 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 andor hormonal therapy andor adjuvant trastuzumab at the description of the treating physician
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None