Breast, Phase II
An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)
Volunteers
Health Professionals
What is the purpose of this trial?
This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Brooke Chaves
- D. Barry Boyd, MD, MS
- Daniel O'Neil, MD, MPH
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Elizabeth Cappiello
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Ian Krop, MD, PhD
- Jade Vanacore
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Javin Brita, PA
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karishma Mehra, MBBS
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kathryn Mason
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Lajos Pusztai, MD, DPhil
- Laura Sabourin
- M. Sung Lee, MD
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Matthew Austin, MD
- Michael Cohenuram, MD
- Michael Grant, MD
- Michelle Corso
- Neal Fischbach, MD
- Pawan Karanam, MD
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Elizabeth Schellhorn, MD
- Sharynn Hall, MD, PhD
- Stephanie Paine, APRN
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Tara Sanft, MD
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated11/03/2023
- Study HIC#2000025449