Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment capecitabine
Phase phase 2
Sponsor University of Chicago
Collaborator Breast Cancer Research Foundation
Start date September 2006
End date February 2014
Trial size 48 participants
Trial identifier NCT00347438, 14201B

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 and emotional well-being and how well the participants on capecitabine follow the study drug plan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
capecitabine Xeloda
Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).

Primary Outcomes

Measure
overall, partial, clinical complete and pathological complete response rate
time frame: indefinite

Secondary Outcomes

Measure
genomic markers of response
time frame: unknown
toxicity and adverse events
time frame: unknown

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer
Principal investigator Olufunmilayo I Olopade, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by University of Chicago.