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:
Ariel Karwat,
Yan Fon Mei,
Danielle Seidman,
Natalie Jill Klar,
Freya R. Schnabel,
Yuliya Sundatova,
Jonathan So,
Sylvia Adams,
Yael Simons,
Caitlin Elizabeth Ryan,
Benjamin Cooper,
Maryann J Kwa,
Nina D'Abreo,
Yelena Novik,
Deborah M Axelrod,
Amanda Marie Buzolich,
Gregory Edward Totero,
Olivier Maisonet,
Oren Cahlon,
Amy N. Solan,
Thomas B. Daniels,
Jonathan Haas,
Nancy Chan,
Alexander A Hindenburg,
Douglas K Marks.
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