Breast, Phase III
A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
Volunteers
Health Professionals
What is the purpose of this trial?
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Anca Bulgaru, MD
- Andrea Brennan, PA
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS, MD
- Benjamin Newton, MD
- Carlotta C. Evans, APRN
- Christina Santore, APRN
- Claire Aurilio
- Clarice Grens, APRN
- D. Barry Boyd, MD, MS
- Daniel O'Neil, MD, MPH
- Elan Gorshein, DO, JD, MPH
- Elizabeth Gaa, APRN
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham, APRN
- Ian Krop, MD, PhD
- Jadwiga Kretowicz, APRN
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Jing Du, MD, PhD, MHS
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katelyn Scott, APRN
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kathryn Mason, APRN
- Kayla Martello
- Kert Sabbath, MD, FACP
- Lajos Pusztai, MD, DPhil
- Larisa Fleysher, APRN
- Laura Sabourin
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Matthew Austin, MD
- Melissa Gambaccini, APRN, AOCNP, FNP-C
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michael Grant, MD
- Michelle Corso, APRN
- Neal Fischbach, MD
- Pawan Karanam, MD
- Rebecca Vanasse-Passas, MD
- Robert Legare, MD
- Sara Anastasio, APRN, RN
- Sarah Carlson, PA
- Sarah Thomen, APRN
- Sarah Elizabeth Schellhorn, MD
- Sharynn Hall, MD, PhD
- Stacey LaRosa, APRN
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy, APRN
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated04/12/2026
- Study IRB#2000040635