A Phase 1b/2, Open-Label, Multicohort Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
Volunteers
Health Professionals
What is the purpose of this trial?
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer).
This study is seeking participants who:
- have breast cancer that is hard to treat and has spread in the body (advanced cancer)
- have tumors that have HER2 on them
- have received previous treatment for their advanced breast cancer
All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein).
Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks.
The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.
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Principal Investigator
Sub-Investigators
- Adriana Kahn, MD
- Agatha Hecht
- Alessia Donadio, MD
- Anca Bulgaru, MD
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Bryanne Pappas
- Christina Santore
- Claire Aurilio
- Clarice Grens
- D. Barry Boyd, MD, MS
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- Jadwiga Kretowicz
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Jing Du, MD, PhD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katelyn Scott
- 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
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Matthew Austin, MD
- Melissa Gambaccini, APRN, AOCNP, FNPC
- Michael DiGiovanna, MD, PhD
- Michael Grant, MD
- Michelle Corso
- Neal Fischbach, MD
- Pawan Karanam, MD
- 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
- Vanna Dest
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated01/07/2026
- Study HIC#2000040649