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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00645866
First received: March 27, 2008
Last updated: May 13, 2011
Last verified: May 2011

March 27, 2008
May 13, 2011
April 2003
March 2006   (final data collection date for primary outcome measure)
  • Pathologic response rate [ Designated as safety issue: No ]
  • Toxicity patterns [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00645866 on ClinicalTrials.gov Archive Site
Overall survival [ Designated as safety issue: No ]
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.

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Interventional
Phase 2
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
March 2006
March 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00645866
CDR0000582618, P30CA015083, MC0132, 595-02, 378-ONC-0030-241
Yes
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