NCT00010140

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

September 1, 2005

First QC Date

February 2, 2001

Last Update Submit

December 17, 2013

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (3)

  • Disease-free survival

  • Overall survival

  • Incidence of thromboembolic events during the first 9 months after randomization

Secondary Outcomes (2)

  • Tolerability

  • Quality of life

Interventions

docetaxelDRUG
epirubicin hydrochlorideDRUG
tamoxifen citrateDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven node-positive breast cancer * Postmenopausal * Last menstrual period more than 12 months before initial surgery OR * Any age with prior bilateral oophorectomy OR * Age 50 or over with prior hysterectomy without oophorectomy (unrelated to malignancy) * No distant metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * See Disease Characteristics Sex: * Female Menopausal status: * See Disease Characteristics Performance status: * WHO (ECOG) 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 OR * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * SGOT and SGPT no greater than 1.5 times normal * Alkaline phosphatase no greater than 1.5 times normal Renal: * Creatinine less than 1.5 times normal Cardiovascular: * No history of significant angina, congestive heart failure, or myocardial infarction within the past year * No clinically significant arrhythmias or uncontrolled hypertension * LVEF normal by MUGA, LV gated scan, or echocardiogram Other: * No other concurrent serious illness * No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital

London, England, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelEpirubicinTamoxifenChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesStilbenesBenzylidene CompoundsBenzene DerivativesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci

    Hammersmith Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

August 1, 1997

Last Updated

December 18, 2013

Record last verified: 2005-09

Locations

GB(1)