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Tamoxifen in Treating Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003678
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: March 2007

November 1, 1999
December 18, 2013
May 1991
Not Provided
All-cause mortality [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003678 on ClinicalTrials.gov Archive Site
  • Disease recurrence [ Designated as safety issue: No ]
  • Death due to breast cancer, other primary tumors, or cardiovascular causes [ Designated as safety issue: No ]
Not Provided
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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.

OBJECTIVES:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Drug: tamoxifen citrate
  • Procedure: adjuvant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20000
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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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00003678
CDR0000066779, CRC-TU-ATTOM, EU-98042, ISRCTN17222211
Not Provided
Not Provided
University Hospital Birmingham
Not Provided
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