Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00148720
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.
Study:
NCT00148720
Study Brief:
Protocol Section:
NCT00148720