Status:
TERMINATED
Capecitabine in Women With Operable Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Hoffmann-La Roche
Beth Israel Deaconess Medical Center
Conditions:
Invasive Breast Carcinoma
Primary Invasive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
* 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00148720
Start Date
September 1 2004
Last Update
November 11 2015
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Faulkner Hospital
Boston, Massachusetts, United States, 02130
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215