Breast, Phase III
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Volunteers
Health Professionals
What is the purpose of this trial?
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Alice Wnuk
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Brooke Chaves
- Christi Kim, MD, FACP
- 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
- 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
- Kathleen Fenn, MD
- Kathryn Mason
- Kayla Martello
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Lajos Pusztai, MD, DPhil
- Larisa Fleysher
- Laura Sabourin
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Matthew Austin, MD
- Meena S. Moran, MD
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michael Grant, MD
- Michelle Corso
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Renee Moye
- Robert Legare, 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 Updated04/26/2024
- Study HIC#2000036469