Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer (NCT06058377)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (555 Sites)
Showing the first 25 of 555 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Katmai Oncology Group — Anchorage, Alaska
- University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- University of Arizona Cancer Center-North Campus — Tucson, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Sutter Auburn Faith Hospital — Auburn, California
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
- Tower Cancer Research Foundation — Beverly Hills, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Palo Alto Medical Foundation-Fremont — Fremont, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- City of Hope at Irvine Lennar — Irvine, California
- City of Hope Antelope Valley — Lancaster, California
- Loma Linda University Medical Center — Loma Linda, California
- City of Hope at Long Beach Elm — Long Beach, California
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Memorial Medical Center — Modesto, California
- City of Hope Newport Beach — Newport Beach, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Desert Regional Medical Center — Palm Springs, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Anatomic Stage II Breast Cancer AJCC v8
- T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial — Birmingham, Alabama
- Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer — Columbus, Ohio
- Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial — Birmingham, Alabama
- Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer — Los Angeles, California
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy — Birmingham, Alabama
- An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial — Rochester, Minnesota
Explore by condition: All Anatomic Stage II Breast Cancer AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.