Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer
|ClinicalTrials.gov Identifier: NCT00645866|
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : May 16, 2011
RATIONALE: Drugs used in chemotherapy, such as epirubicin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or stage IIIB breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine Drug: docetaxel Drug: epirubicin hydrochloride Other: laboratory biomarker analysis Other: pharmacogenomic studies Procedure: biopsy Procedure: neoadjuvant therapy Procedure: therapeutic surgical procedure||Phase 2|
- Describe the pathologic response rate in chemotherapy-naive women with locally advanced breast cancer (stage IIIA or IIIB) after 6 courses of sequential neoadjuvant therapy with epirubicin hydrochloride and a combination of docetaxel with capecitabine .
- Describe the adverse events of sequential epirubicin hydrochloride and a combination of docetaxel with capecitabine in this patient population.
- Identify by transcriptional profiling the differential expression of candidate gene products that confer chemosensitivity to epirubicin hydrochloride, docetaxel, and capecitabine.
- Correlate the differential expression of known genetic polymorphisms of intracellular regulators involved in the metabolism of epirubicin hydrochloride, docetaxel, and capecitabine with adverse events and tumor response.
- Assess individual patient variation in clinical (toxicity and/or activity), in pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to epirubicin hydrochloride, docetaxel, and capecitabine due to genetic differences in proteins involved in drug response (transport, metabolism and/or mechanism of action).
OUTLINE: Patients receive epirubicin hydrochloride IV on day 1. Treatment repeats every 2 weeks for 3 courses. Beginning 2 weeks after last dose of epirubicin hydrochloride, patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Treatment with docetaxel and capecitabine repeats every 3 weeks for 3 courses. Patients then undergo surgery.
Blood samples are collected at baseline for pharmacogenetic studies. Tumor tissue samples are collected at baseline and periodically during treatment for correlative laboratory studies.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Masking:||None (Open Label)|
|Official Title:||A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- Pathologic response rate
- Toxicity patterns
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645866
|Study Chair:||Julian R. Molina, MD, PhD||Mayo Clinic|
|Principal Investigator:||James N. Ingle, MD||Mayo Clinic|
|Principal Investigator:||Wilma Lingle, PhD||Mayo Clinic|