A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic response rate
Safety Issue:
No
Principal Investigator
Julian R. Molina, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000582618
NCT ID:
NCT00645866
Start Date:
April 2003
Completion Date:
March 2006
Related Keywords:
- Breast Cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|
