Capecitabine in Women With Operable Breast Cancer (NCT00148720) | Clinical Trial Compass
TerminatedPhase 2
Capecitabine in Women With Operable Breast Cancer
Stopped: Slow accrual
United States80 participantsStarted 2004-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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.
What they're measuring
1
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.