NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I HORMONE SENSITIVE HER2-NEGATIVE ONCOTYPE RECURRENCE SCORE = 18 BREAST CANCER

Brief description of study

Primary Objective To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of ipsilateral-breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Primary Hypothesis Breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral-breast tumor recurrence (IBTR) as compared to breast conservation, breast radiation, and endocrine therapy.


Clinical Study Identifier: s21-00798
ClinicalTrials.gov Identifier: NCT04852887
Principal Investigator: Naamit K. Gerber.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Ariel Karwat, Shridar Ganesan, Yan Fon Mei, Danielle Seidman, Natalie Jill Klar, Yelena Novik, Yuliya Sundatova, Oren Cahlon, Neil Vasan, Jonathan So, Freya R. Schnabel, Yael Simons, Benjamin Cooper, Maryann J Kwa, Nina D'Abreo, Deborah M Axelrod, Stephanie M Erichsen, Alana Grace Spadalik, Amanda Marie Buzolich, Gregory Edward Totero, Anastasiya Apanasyuk, Olivier Maisonet, Ruth Oratz, Maggie Tang, Marleen I Meyers, Amy N. Solan, Thomas B. Daniels, Wanqing Iris Zhi, Jonathan Haas, Nancy Chan, Phyu Phyu Soe, Douglas K Marks, Alexander A Hindenburg.


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