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Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer



Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

For Condition: stage 2 breast cancer,stage 1 breast cancer,stage 3C breast cancer,stage 3B breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): University of Oxford ,
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of prolonged tamoxifen with that of shorter tamoxifen therapy in treating patients who have had a breast tumor removed.
Details: OBJECTIVES: - Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen. OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years. Patients are followed annually. PROJECTED ACCRUAL: Approximately 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: - Curatively treated carcinoma of the breast - Currently taking adjuvant tamoxifen - Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen) PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - No contraindications to receiving tamoxifen - No other serious medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy allowed Chemotherapy: - Prior chemotherapy allowed Endocrine therapy: - See Disease Characteristics Radiotherapy: - Prior radiotherapy allowed Surgery: - Prior surgery allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ChristopherWilliams,  Study Chair,  Cochrane Cancer Network

Cochrane Cancer Network *Recruiting*
Oxford,  England,  OX3 7LF
United Kingdom
Recruiting Christopher  Williams 44-1865-226-628


Additional Information:
Study ID Numbers:
  CDR0000065596;  ATLAS,EU-96064
Study Start Date: 
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003016

Other Stage 3b Breast Cancer Studies:
1. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

2. Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer

3. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

4. Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

5. Combination Chemotherapy in Treating Women With Breast Cancer

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Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

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