Clinical trialNCT06058377RecruitingPhase 3Interventional

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

SponsorNational Cancer Institute (NCI)Enrollment3,680Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Negative Breast CarcinomaHormone Receptor-Positive Breast Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (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 High 2 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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Erin F Cobain
SWOG Cancer Research Network
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

553 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Centro Comprensivo de Cancer de Upr
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
Proncology
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Mauricio R. Escobar
Recruiting
Katmai Oncology Group
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Sima Ehsani Chimeh
Recruiting
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Sima Ehsani Chimeh
Recruiting
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Sima Ehsani Chimeh
Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Jay W. Carlson
Recruiting
Nea Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Ryan A. Yates
Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sindhu Malapati
Recruiting
Sutter Auburn Faith Hospital
Auburn, California, United States
Kristie A. Bobolis
Recruiting
Ais Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Nicole Gordon
Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Kristie A. Bobolis
Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, United States
Jin Sun L. Bitar
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Irene M. Kang
Recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Kristie A. Bobolis
Recruiting
City of Hope at Irvine Lennar
Irvine, California, United States
Irene M. Kang
Recruiting
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Ritesh Parajuli
Recruiting
City of Hope Antelope Valley
Lancaster, California, United States
Irene M. Kang
Recruiting
Loma Linda University Medical Center
Loma Linda, California, United States
Gayathri Nagaraj
Recruiting
City of Hope at Long Beach Elm
Long Beach, California, United States
Irene M. Kang
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Jin Sun L. Bitar
Recruiting
the Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
Jin Sun L. Bitar
Recruiting
Memorial Medical Center
Modesto, California, United States
Kristie A. Bobolis
Recruiting
City of Hope Newport Beach
Newport Beach, California, United States
Irene M. Kang
Recruiting
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Ritesh Parajuli
Recruiting
Desert Regional Medical Center
Palm Springs, California, United States
Soe T. Maunglay
Recruiting
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Kristie A. Bobolis
Recruiting
Huntington Memorial Hospital
Pasadena, California, United States
Jin Sun L. Bitar
Recruiting
Sutter Roseville Medical Center
Roseville, California, United States
Kristie A. Bobolis
Recruiting
Swog
Sacramento, California, United States
Erin F. Cobain
Recruiting
Sutter Medical Center Sacramento
Sacramento, California, United States
Kristie A. Bobolis
Recruiting
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kristie A. Bobolis
Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Active, not recruiting
Mills Health Center
San Mateo, California, United States
Kristie A. Bobolis
Recruiting
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Kristie A. Bobolis
Recruiting
Saint John'S Cancer Institute
Santa Monica, California, United States
Parvin F. Peddi
Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States
Charles W. Drescher
Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Charles W. Drescher
Recruiting
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Kristie A. Bobolis
Recruiting

513 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cyclophosphamide →Doxorubicin →Durvalumab →Paclitaxel →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Nov 2023
Primary completion: 31 May 2032
Completion: 31 May 2032
Last update posted: 20 Aug 2026
Registered enrollment: 3,680
Registry id: NCT06058377

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.