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MA39 Details
Status: Open 
Activation Date: 2018MAY30
Phase: III 

Description: Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer 

Eligibility: 1) Newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases. 2) Must have been treated by BCS or mastectomy. 3) If treated by BCS or mastectomy and axillary dissection must have 1-3 positive axillary nodes. 4) If treated by BCS and SLNB alone must have only 1-2 positive axillary nodes. 5) If treated by mastectomy and SLNB alone must have only 1 positive axillary node. 6) Must be ER greater than or equal to 1% and Her2 negative on local testing. 7) Must have an Oncotype DX recurence score of less than 18. 8) Must consent to provision of tissue and blood for mandatory correlative studies 9) Must have had endocrine therapy initiated or planned for greater than or equal to 5 years 10) ECOG performance status must be 0,1 or 2. 11) Age must be greater than or equal to 40 years. 12) Life expectancy must be greater than or equal to 10 years. 

Objective: Primary: To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC. Secondary: 1) Invasive disease-free survival (DFS); 2) Breast cancer mortality; 3) Overall survival (OS); 4) Locoregional recurrence-free interval (LRRFI); 5) Distant recurrence-free interval (DRFI); 6) Toxicity; 7) Arm volume and mobility 8) Patient reported outcomes (PROs) and Quality of Life (QOL); 9) Cost effectiveness Tertiary: 1) To establish a comprehensive tumour bank; 2) To evaluate the ability of intrinsic subtype to predict study outcomes and the effect of regional RT on these outcomes; 3) To evaluate other radiation signatures to prognosticate and predict effect of regional RT; 4) To describe the prevalence of ctDNA and evaluate its prognostic ability 

Participation: Open to member centres 

Lay Description: Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to compare the effects on women with low risk breast cancer of 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.  

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