Breast, Phase III
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 Less Than or Equal to 25 (OFSET)
Volunteers
Health Professionals
What is the purpose of this trial?
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
- Trial withNRG Oncology
- Ages18 years and older
- GenderFemale only
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Principal Investigator
Sub-Investigators
- Adriana Matutino Kahn, MD
- Agatha Hecht
- Alessia Donadio, MD
- Alice Mookerjee
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Clarice Grens
- D. Barry Boyd, MD, MS
- Daniel O'Neil, MD, MPH
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kathryn Mason
- Kayla Martello
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Lajos Pusztai, MD, DPhil
- Larisa Fleysher
- Laura Sabourin
- M. Sung Lee, MD
- Madeline Santiago
- Mariya Rozenblit, MD
- Matthew Austin, MD
- Meena S. Moran, MD
- Melissa Gambaccini
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michael Grant, MD
- Michelle Corso
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Robert Legare, MD
- Robert Matera, MD
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Thomen, APRN
- Sarah Elizabeth Schellhorn, MD
- Sharynn Hall, MD, PhD
- Stacey LaRosa
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Tara Sanft, MD
- Vanna Dest
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated01/05/2025
- Study HIC#2000036471