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Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Sponsor: National Cancer Institute (NCI)
Summary
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.
Official title: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3680
Start Date
2023-11-27
Completion Date
2032-05-31
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo optional collection of tissue and/or blood
Cyclophosphamide
Given IV
Doxorubicin
Given IV
Durvalumab
Given IV
Genetic Testing
Undergo MammaPrint testing
Mammography
Undergo mammography
Paclitaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Locations (564)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Katmai Oncology Group
Anchorage, Alaska, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Memorial Medical Center
Modesto, California, United States
City of Hope Newport Beach
Newport Beach, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
SWOG
Sacramento, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Mills Health Center
San Mateo, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Saint John's Cancer Institute
Santa Monica, California, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California, United States
City of Hope South Bay
Torrance, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
City of Hope Upland
Upland, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
UCI Health - Yorba Linda
Yorba Linda, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
UCHealth - Cherry Creek
Denver, Colorado, United States
Shaw Cancer Center
Edwards, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Schulze Family Foundation Cancer Clinic - Bonita Health Center
Bonita Springs, Florida, United States
Morton Plant Hospital
Clearwater, Florida, United States
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Mease Countryside Hospital
Safety Harbor, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
Winter Haven Hospital
Winter Haven, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States