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

Breast Cancer Clinical Trial

Official title:

A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645866
• Other study ID #: CDR0000582618
• Secondary ID: P30CA015083MC013
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2008
• Last updated: May 13, 2011
• Start date: April 2003
• Est. completion date: March 2006

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine

• docetaxel

• epirubicin hydrochloride

Other:
• laboratory biomarker analysis

• pharmacogenomic studies

Procedure:
• biopsy

• neoadjuvant therapy

• therapeutic surgical procedure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic response rate			No
Primary	Toxicity patterns			Yes
Secondary	Overall survival			No