Capecitabine in Women With Operable Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Invasive Breast Carcinoma, Primary Invasive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of primary invasive breast cancer Stage I-III operable breast cancer. Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation Women greater than 18 years of age ECOG performance status 0-1 WBC > 4000/mm3 Platelet count > 100,000/mm3 SGOT < 2x ULN Calculated creatinine clearance > 50ml/min Exclusion Criteria: Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study. Pregnant or breast-feeding women Inflammatory breast cancer HER2 positive disease History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency Uncontrolled intercurrent illness Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant. Excisional biopsy performed prior to enrollment Uncontrolled coagulopathy Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine|Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Breast Cancer, Operable Breast Cancer, Capecitabine