Capecitabine in Women With Operable Breast Cancer

Stage II Breast Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT00148720
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Terminated
• Phase: Phase 2
• Start date: September 2004