Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
Recruitment status was Active, not recruiting
|First Received Date ICMJE||July 5, 2000|
|Last Updated Date||August 6, 2013|
|Start Date ICMJE||January 1992|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006030 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer|
|Official Title ICMJE||Protocol of a Randomized Trial for the Management of Small Well-Differentiated and Special Type Carcinomas of the Breast|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Breast Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically confirmed unilateral stage I invasive breast cancer No more than 1 tumor and no greater than 2 cm Grade 1 tumor of any histological type OR No special type OR Mixed type allowed No lymph node involvement No in situ carcinoma only or ductal carcinoma in situ with microinvasion No vascular invasion No Paget's disease of the nipple Well differentiated special type of primary mammary carcinoma including: Tubular Tubular/cribriform Cribriform Papillary Mucoid No lobular, medullary, or other rarer types of mammary carcinomas including: Adenoid cystic Carcinoid Secretory Spindle cell Apocrine No distant metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Under 70 Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No other systemic disease that may preclude study No other prior malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: No other concurrent adjuvant systemic therapy
|Ages||up to 70 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT00006030|
|Other Study ID Numbers ICMJE||BASO-BREAST-BASO-II, CDR0000068043, EU-20019, ISRCTN47734678|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||British Association of Surgical Oncology: Breast Group|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||December 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP