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Tamoxifen in Treating Women With Breast Cancer



Tamoxifen in Treating Women With Breast Cancer

For Condition: stage 2 breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: 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: Randomizedphase 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.
Details: 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. PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DanielRea,  Study Chair,  Queen Elizabeth Hospital at University of Birmingham

Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham,  England,  B15 2TH
United Kingdom
Recruiting Daniel  Rea 44-121-472-1311


Additional Information:
Study ID Numbers:  CDR0000066779;  CRC-TU-ATTOM,EU-98042,ISRCTN17222211
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003678

Other Stage 1 Breast Cancer Studies:
1. Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer

2. Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer

3. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

4. Cryosurgery in Treating Women With Breast Lesions

5. Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

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