Tamoxifen in Treating Women With Breast Cancer

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: tamoxifen citrate; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00003678

CRC-TU-ATTOM

CDR0000066779

ISRCTN17222211

EU-98042

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and 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