Spots Global Cancer Trial Database for Capecitabine in Women With Operable Breast Cancer

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Trial Identification

Brief Title: Capecitabine in Women With Operable Breast Cancer

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

Study ID: NCT00148720

Conditions

Invasive Breast Carcinoma

Primary Invasive Breast Cancer

Stage I Breast Cancer

Stage II Breast Cancer

Stage III Breast Cancer

Interventions

Capecitabine

Study Description

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.