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Tamoxifen in Treating Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003678
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
December 19, 2013
May 1991
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All-cause mortality
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Complete list of historical versions of study NCT00003678 on Archive Site
  • Disease recurrence
  • Death due to breast cancer, other primary tumors, or cardiovascular causes
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Tamoxifen in Treating Women With Breast Cancer
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

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.


  • Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.

OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
  • Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.

Patients are followed annually.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Drug: tamoxifen citrate
  • Procedure: adjuvant therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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



  • Not specified


  • Female

Menopausal status:

  • Any status allowed

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • See Disease Characteristics


  • Not specified


  • See Disease Characteristics


  • Any primary treatment allowed
Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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University Hospital Birmingham
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Study Chair: Daniel Rea, MD University Hospital Birmingham
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP