NCT00003678

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

Trial Health

55
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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

May 1, 1991

Completed
8.5 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

December 19, 2013

Status Verified

March 1, 2007

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

Secondary Outcomes (2)

  • Disease recurrence

  • Death due to breast cancer, other primary tumors, or cardiovascular causes

Interventions

tamoxifen citrateDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed breast carcinoma that has been completely excised * Clinically relapse free * Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen * No significant endometrial hyperplasia * No patients with negligibly low risk of breast cancer death * Hormone receptor status: * Any status allowed PATIENT CHARACTERISTICS: Age: * Not specified Sex: * Female Menopausal status: * Any status allowed Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other life threatening disease * No retinopathy * No psychiatric disorder or other condition that would preclude study compliance * No serious toxicity (e.g., depression) thought to be due to tamoxifen * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * Any primary treatment 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)

Cancer Research UK Clinical Trials Unit - Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Related Publications (7)

  • Gray R, Davies C, Perry P. Tamoxifen for early breast cancer: better late than never. Ann Oncol. 2000 May;11(5):505-7. doi: 10.1023/a:1008323116265. No abstract available.

    PMID: 10907940BACKGROUND

  • Rea D, Poole C, Gray R. Adjuvant tamoxifen: how long before we know how long? BMJ. 1998 May 16;316(7143):1518-9. doi: 10.1136/bmj.316.7143.1518. No abstract available.

    PMID: 9582148BACKGROUND

  • Earl H, Gray R, Kerr D, Lee M. The optimal duration of adjuvant tamoxifen treatment for breast cancer remains uncertain: randomize into aTTom. Clin Oncol (R Coll Radiol). 1997;9(3):141-3. doi: 10.1016/s0936-6555(97)80067-2. No abstract available.

    PMID: 9269542BACKGROUND

  • Earl H, Baker P, Kerr D, Lee M, Gray R, Baum M. Adjuvant treatment with tamoxifen. Recruitment into studies assessing optimum duration of treatment must continue. BMJ. 1996 Apr 20;312(7037):1036-7. doi: 10.1136/bmj.312.7037.1036b. No abstract available.

    PMID: 8616358BACKGROUND

  • Gray R. Tamoxifen: how boldly to go where no women have gone before. J Natl Cancer Inst. 1993 Sep 1;85(17):1358-60. doi: 10.1093/jnci/85.17.1358. No abstract available.

    PMID: 8350355BACKGROUND

  • Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25. No abstract available.

    PMID: 35213039DERIVED

  • Bartlett JMS, Sgroi DC, Treuner K, Zhang Y, Ahmed I, Piper T, Salunga R, Brachtel EF, Pirrie SJ, Schnabel CA, Rea DW. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial. Ann Oncol. 2019 Nov 1;30(11):1776-1783. doi: 10.1093/annonc/mdz289.

    PMID: 31504126DERIVED

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

  • Daniel Rea, MD

    University Hospital Birmingham

    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

May 1, 1991

Last Updated

December 19, 2013

Record last verified: 2007-03

Locations

GB(1)