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RECRUITING
NCT06058377
PHASE3

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)

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo optional collection of tissue and/or blood

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

BIOLOGICAL

Durvalumab

Given IV

OTHER

Genetic Testing

Undergo MammaPrint testing

PROCEDURE

Mammography

Undergo mammography

DRUG

Paclitaxel

Given IV

OTHER

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

And 464 more locations on ClinicalTrials.gov