Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148720
Status:
TERMINATED
Last Update Posted:
2015-11-11
First Post:
2005-09-07
Brief Title:
Capecitabine in Women With Operable Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 good and bad taking capecitabine for 12 weeks before surgery will have on women with breast cancer
Detailed Description:
Prior to the start of treatment patients will have a small metal clip inserted into the tumor bed to identify the tumor site to the surgeon At that time a needle biopsy of the breast tumor or a sentinel underarm lymph node biopsy will also be performed
Patients will take capecitabine orally twice daily for 14 days This treatment will repeat every 21 days 1 cycle Patients will receive 4 cycles of this treatment
A physical exam and blood work will be done every three weeks after starting therapy to monitor side effects
After two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine
After completing 4 cycles 12 weeks of capecitabine patients will then undergo surgery to remove any remaining breast cancer lumpectomy or mastectomy Post-surgical treatment radiation chemotherapy and hormonal therapy is at the discretion of the patients physician
Patients will take capecitabine orally twice daily for 14 days This treatment will repeat every 21 days 1 cycle Patients will receive 4 cycles of this treatment
A physical exam and blood work will be done every three weeks after starting therapy to monitor side effects
After two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine
After completing 4 cycles 12 weeks of capecitabine patients will then undergo surgery to remove any remaining breast cancer lumpectomy or mastectomy Post-surgical treatment radiation chemotherapy and hormonal therapy is at the discretion of the patients physician
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