NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1 ER Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score = 25 (OFSET)
Brief description of study
This study wants to see if giving extra chemotherapy (adjuvant chemotherapy (ACT) to ovarian function suppression plus endocrine therapy) helps premenopausal women with early-stage breast cancer. The study team wants to know if adding this extra treatment (ACT) can improve survival rates and keep the cancer from coming back. The study team is also checking if the extra treatment causes more menopausal symptoms or more pain during other treatments. Additionally, they'll look at how well patients stick to their treatment plan, the effect on their ovaries, any long-term side effects, and how their quality of life is affected.
Clinical Study Identifier: s23-01288
ClinicalTrials.gov Identifier: NCT05879926
Principal Investigator:
Nina D'Abreo.
Other Investigators:
Yelena Novik,
Maryann J Kwa,
Douglas K Marks,
Marleen I Meyers,
Danielle Seidman,
Ariel Karwat,
Amanda Marie Buzolich,
Sylvia Adams,
Yan Fon Mei,
Yael Simons,
Nancy Chan,
Caitlin Elizabeth Ryan,
Anastasiya Apanasyuk,
Ruth Oratz,
Natalie Jill Klar,
Annmarie Johnson-Rowe,
Alexander A Hindenburg.
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