A Phase II Study of Preoperative Capecitabine in Women With Operable 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
Ian Krop, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Faulkner Hospital||Jamaica Plain, Massachusetts 02130|