Breast, Phase III
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Volunteers
Health Professionals
What is the purpose of this trial?
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
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Principal Investigator
Sub-Investigators
- Adriana Matutino Kahn, MD
- Agatha Hecht
- Alessia Donadio, MD
- Alice Wnuk
- Alison Johnson
- Andrea Brennan
- Armand Russo, MD
- Beverly Drucker, MD, PhD
- D. Barry Boyd, MD, MS
- Daniel O'Neil, MD, MPH
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- Jade Vanacore
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karishma Mehra, MBBS
- Kathleen Fenn, MD
- Kathryn Mason
- Kayla Martello
- Kristen Hoxie
- Lajos Pusztai, MD, DPhil
- Larisa Fleysher
- Laura Sabourin
- M. Sung Lee, MD
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michelle Corso
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Renee Moye
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Elizabeth Schellhorn, MD
- Su Hsien Lim, MD
- Tara Sanft, MD
- Vanna Dest
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated04/28/2024
- Study HIC#2000033661