Capecitabine in Women With Operable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00148720|
Recruitment Status : Terminated (Slow accrual)
First Posted : September 8, 2005
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Invasive Breast Carcinoma Primary Invasive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer||Drug: Capecitabine||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||September 2007|
- Drug: Capecitabine
Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles
- To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148720
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02130|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Ian Krop, MD, PhD||Dana-Farber Cancer Institute|