Status:
TERMINATED
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Breast Cancer Research Foundation
Roche Pharma AG
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery. The study will also help gain more information about the effects of the capecitabine on physical an...
Eligibility Criteria
Inclusion
- Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
- Ability to provide written informed consent prior to study-specific screening procedures
- TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
- Age 18 years or older
- Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
- Performance status 0-1
- Required Initial Laboratory Data:
- Granulocytes \>=1,200/µl
- Platelet count \>=100,000/µl
- Calculated Creatinine Clearance \> 30 mL/min
- Total bilirubin \<= Upper Limit Normal
- Alkaline Phosphatase \<=Upper Limit Normal
- SGPT, SGOT \<=Upper Limit Normal
- Normal chest x-ray
Exclusion
- HER2 positive breast cancer
- Pregnant or lactating woman
- Life expectancy \< 3 months
- Serious, uncontrolled, concurrent infection(s)
- Any prior fluoropyrimidine therapy or other chemotherapy
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
- Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
- Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
- Any of the following laboratory values:
- Abnormal hematologic values (neutrophils \< 1.0 x 109/L, platelet count \< 100 x 109/L)
- Impaired renal function (estimated creatinine clearance \<30ml/min as calculated with Cockcroft-Gault equation)
- Serum bilirubin \> upper normal limit.
- SGOT, SGPT \> upper normal limit
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00347438
Start Date
September 1 2006
End Date
March 1 2013
Last Update
December 14 2015
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
University of Ibadan
Ibadan, Nigeria
3
Obafemi Awolowo University
Ile-Ife, Nigeria