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NCT02889874
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This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.
Inclusion Criteria: for registration in the study: 1. Female patients aged = 50 years of any menopausal status. 2. Primary tumour characteristics as assessed by conventional histopathology: * Unifocal histologically confirmed invasive breast carcinoma * Maximum microscopic size =2 cm * Grade 1 or 2 histology * ER and PR positive in =10% of tumour cells in either the biopsy or breast conserving surgical specimen * HER2 negative on IHC (score 0 or 1+) or in situ hybridisation (ERBB2-amplification .... Read more
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Sample Size Not Available
Min. age 50 Years
Max. age N/A
Sex Female
Condition category Radiation therapy , breast cancer , non-inferiority , omission
Condition code Early Stage Breast Carcinoma
Intervention code Treatment: Other - Omission of radiation therapy
A: Radiation Therapy & endocrine therapy No intervention Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care). B: No Radiation Therapy (ET only) Experimental Patients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only. Treatment: Other: Omission of radiation therapy Omission of radiation therapy (adjuvant endocrine therapy only).
Control group Not available
Comparison not available.
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