Know Cancer

or
forgot password

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


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

All-cause mortality

Safety Issue:

No

Principal Investigator

Daniel Rea, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000066779

NCT ID:

NCT00003678

Start Date:

May 1991

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location