Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645866
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : May 16, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

March 27, 2008
March 28, 2008
May 16, 2011
April 2003
March 2006   (Final data collection date for primary outcome measure)
  • Pathologic response rate
  • Toxicity patterns
Same as current
Complete list of historical versions of study NCT00645866 on Archive Site
Overall survival
Same as current
Not Provided
Not Provided
Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer
A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer

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.



  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2006
March 2006   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed breast cancer

    • Stage IIIA or IIIB disease (T3 N1 M0, T4 N1 M0, any T N2/N3 M0)
  • Bidimensionally measurable or evaluable disease
  • Hormone receptor status not specified


  • Menopausal status not specified
  • ECOG performance status 0-2
  • Platelet count ≥ 100,000 cells/μL
  • Total bilirubin normal
  • Hemoglobin ≥ 8.0 g/dL
  • ANC ≥ 1,000 cells/μL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine clearance ≥ 50 mL/min and serum creatinine normal
  • Life expectancy ≥ 3 months
  • No uncontrolled infection
  • No chronic debilitating disease
  • No lack of physical integrity of the upper gastrointestinal tract
  • Able to swallow tablets
  • No malabsorption syndrome
  • No clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias [New York Heart Association class III-IV heart disease] or myocardial infarction within the last 12 months)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or adequately treated other noninvasive carcinomas
  • No peripheral neuropathy ≥ grade 1


  • More than 4 weeks since prior major surgery and recovered
  • No prior chemotherapy regimens including adjuvant therapy
  • No organ allograft
  • No concurrent sorivudine or bruvidine
  • No other concurrent cytostatic, cytotoxic, immunomodulating agents, or radiotherapy
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
P30CA015083 ( U.S. NIH Grant/Contract )
MC0132 ( Other Identifier: Mayo Clinic Cancer Center )
595-02 ( Other Identifier: Mayo Clinic IRB )
378-ONC-0030-241 ( Other Identifier: Pharmacia Protocol )
Not Provided
Not Provided
Julian R. Molina, M.D., Ph.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Julian R. Molina, MD, PhD Mayo Clinic
Principal Investigator: James N. Ingle, MD Mayo Clinic
Principal Investigator: Wilma Lingle, PhD Mayo Clinic
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP