Capecitabine in Women With Operable Breast Cancer

Stopped early · Phase 2

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

In brief

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.

Key facts

Study ID

NCT00148720

Run by

Dana-Farber Cancer Institute

People needed

80

Starts

2004-09-01

Last updated by the study team

2015-11-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Faulkner Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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