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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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Pathologic response rate [ Designated as safety issue: No ]
  • Toxicity patterns [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: April 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645866

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Julian R. Molina, MD, PhD Mayo Clinic
Principal Investigator: James N. Ingle, MD Mayo Clinic
Principal Investigator: Wilma Lingle, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Julian R. Molina, M.D., Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00645866     History of Changes
Other Study ID Numbers: CDR0000582618, P30CA015083, MC0132, 595-02, 378-ONC-0030-241
Study First Received: March 27, 2008
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Docetaxel
Epirubicin
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014