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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00003678
Date of registration: 01/11/1999
Prospective Registration: No
Primary sponsor: University Hospital Birmingham
Public title: Tamoxifen in Treating Women With Breast Cancer
Scientific title: A Large, Uniquely Simple, Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer
Date of first enrolment: May 1991
Target sample size: 20000
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00003678
Study type:  Interventional
Study design:  Allocation: Randomized, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
United Kingdom
Contacts
Name:     Daniel Rea, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital Birmingham
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Breast Cancer
Intervention(s)
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Primary Outcome(s)
All-cause mortality [Time Frame: No]
Secondary Outcome(s)
Death due to breast cancer, other primary tumors, or cardiovascular causes [Time Frame: No]
Disease recurrence [Time Frame: No]
Secondary ID(s)
CDR0000066779
CRC-TU-ATTOM
EU-98042
ISRCTN17222211
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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