Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer
Brief summary
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.
Detailed 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.
Interventions
DRUGtamoxifen citrate
PROCEDUREadjuvant therapy
Sponsors
University Hospital Birmingham
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease recurrence | — |
| Death due to breast cancer, other primary tumors, or cardiovascular causes | — |
Countries
United Kingdom
Outcome results
None listed