A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study
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Health Professionals
What is the purpose of this trial?
The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
The names of the study drugs involved in this study are:
- Paclitaxel (a type of anti-microtubule agent)
- Docetaxel (a type of anti-microtubule agent)
- Nab-Paclitaxel (a type of anti-microtubule agent)
- Trastuzumab (a type of IgG1 kappa monoclonal antibody)
- Pertuzumab (a type of monoclonal antibody)
- Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)
- Tucatinib (Tyrosine Kinase HER2 Inhibitor)
- Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)
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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
- Daniel O'Neil, MD, MPH
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- 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
- 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
- Rebecca Vanasse-Passas, 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
- Tara Sanft, MD
- Vanna Dest
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Zia Rahman, MD
- Last Updated11/05/2025
- Study HIC#2000039526