Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
|ClinicalTrials.gov Identifier: NCT00006030|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 25, 2004
Last Update Posted : August 7, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. 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. Combining radiation therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen is most effective for stage I breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: tamoxifen citrate Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local excision followed by radiotherapy with or without tamoxifen versus wide local excision plus tamoxifen in women with stage I breast cancer. II. Assess local occurrence in the treated breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of cancer in the opposite breast in these patients when treated with one of these regimens.
OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms. All patients undergo wide local excision of the tumor and axillary node dissection. Arm I: Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35 radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5 years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast|
|Study Start Date :||January 1992|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006030
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Study Chair:||R.W. Blamey||Nottingham City Hospital|