NCT00003016

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer. PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

Trial Health

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Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for phase_3 breast-cancer

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

October 1, 1995

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

October 1, 2002

First QC Date

November 1, 1999

Last Update Submit

February 6, 2009

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Overall survival (i.e., all-cause mortality)

Secondary Outcomes (2)

  • Specific-cause mortality

  • Incidence of second primary tumors

Interventions

tamoxifen citrateDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Curatively treated carcinoma of the breast * Currently taking adjuvant tamoxifen * Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen) PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * No contraindications to receiving tamoxifen * No other serious medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic therapy allowed Chemotherapy: * Prior chemotherapy allowed Endocrine therapy: * See Disease Characteristics Radiotherapy: * Prior radiotherapy allowed Surgery: * Prior surgery allowed

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

Sponsors & Collaborators

Study Sites (1)

Atlas Trial Office

Oxford, England, OX2 6HE, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TamoxifenChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Rodrigo Arriagada, MD

    Karolinska Institutet

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1995

Last Updated

February 9, 2009

Record last verified: 2002-10

Locations

GB(1)