NCT00645866

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

Enrollment Period

2.9 years

First QC Date

March 27, 2008

Last Update Submit

May 13, 2011

Conditions

Breast Cancer

Keywords

stage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

  • Pathologic response rate

  • Toxicity patterns

Secondary Outcomes (1)

  • Overall survival

Interventions

capecitabineDRUG
docetaxelDRUG
epirubicin hydrochlorideDRUG
laboratory biomarker analysisOTHER
pharmacogenomic studiesOTHER
biopsyPROCEDURE
neoadjuvant therapyPROCEDURE
therapeutic surgical procedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CapecitabineDocetaxelEpirubicinPharmacogenomic TestingBiopsyNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesGenetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesCytodiagnosisCytological TechniquesSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeCombined Modality TherapyTherapeutics

Study Officials

  • Julian R. Molina, MD, PhD

    Mayo Clinic

    STUDY CHAIR

  • James N. Ingle, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Wilma Lingle, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2008

First Posted

March 28, 2008

Study Start

April 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 16, 2011

Record last verified: 2011-05