NCT00148720

Capecitabine in Women With Operable Breast Cancer

A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Breast Carcinoma
• Primary Invasive Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-09-01
• First posted: 2005-09-08
• Last updated: 2015-11-11

Locations

3 sites across 1 country: United States