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Recruiting Phase 3 NCT03488693

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Trial Parameters

Condition Breast Cancer
Sponsor Canadian Cancer Trials Group
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 2,140
Sex FEMALE
Min Age 35 Years
Max Age N/A
Start Date 2018-10-16
Completion 2027-09-01
Interventions
RadiationNo Radiation

Brief Summary

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Eligibility Criteria

Inclusion Criteria: * Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care. * Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed. * Patients with T3N0 disease are eligible. * Patients with disease limited to nodal micrometastases are eligible * Patients with nodal macrometastases (\>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, \> 2 mm). * Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, \> 2 mm). * Patients must be ER

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