Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer
Volunteers
Health Professionals
What is the purpose of this trial?
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.
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Principal Investigator
Sub-Investigators
- Adriana Matutino Kahn, MD
- 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
- Christi Kim, MD, FACP
- 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
- 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
- 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
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michael Grant, MD
- Michelle Corso
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Rebecca Vanasse-Passas, 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 Updated07/02/2024
- Study HIC#2000036818