Capecitabine in Women With Operable Breast Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Hoffmann-La Roche
• Treatments: Capecitabine

Criteria

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.