Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
Breast Cancer Research Foundation
Roche Pharma AG
Information provided by (Responsible Party):
Funmi Olopade, University of Chicago
First received: June 29, 2006
Last updated: February 7, 2013
Last verified: February 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- overall, partial, clinical complete and pathological complete response rate [ Time Frame: indefinite ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- genomic markers of response [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
- toxicity and adverse events [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2014 (Final data collection date for primary outcome measure)
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
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).
Other Name: Xeloda
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347438
|University of Chicago
|Chicago, Illinois, United States, 60637 |
|University of Ibadan
|Ibadan, Nigeria |
|Obafemi Awolowo University
|Ile-Ife, Nigeria |
University of Chicago
Breast Cancer Research Foundation
Roche Pharma AG
||Olufunmilayo I Olopade, MD
||University of Chicago
No publications provided
||Funmi Olopade, Institute Senior Fellow, Professor, University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 29, 2006
||February 7, 2013
||United States: Institutional Review Board
Nigeria: Institutional Review Board
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs