Stage II Breast Cancer Clinical Trial
Official title:
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
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.
- 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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