Breast, Phase III
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Volunteers
Health Professionals
What is the purpose of this trial?
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
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Principal Investigator
Sub-Investigators
- Adriana Matutino Kahn, MD
- Agatha Hecht
- Alessia Donadio, MD
- Alice Wnuk
- Alison Johnson
- Andrea Brennan
- Andrea Silber, MD
- 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
- Kerin Adelson, MD
- 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
- Pawan Karanam, MD
- Renee Moye
- Sara Anastasio, RN
- Sarah Carlson
- 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#2000035277