Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148694
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2005-09-07
Brief Title:
Preoperative Cisplatin in Early Stage Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Cisplatin in Early Stage ER- PR- HER-2 Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
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:
The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative ER- progesterone receptor-negative PR- or HER-2 negative breast cancer
Detailed Description:
Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery
Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment
After completion of cisplatin patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast
Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation
Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs After surgery patients will receive standard adjuvant therapy based on discussion with their physician Follow-up progress will occur for several years
Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment
After completion of cisplatin patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast
Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation
Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs After surgery patients will receive standard adjuvant therapy based on discussion with their physician Follow-up progress will occur for several years
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