Brief 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.

Conditions

• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• HER2-Negative Breast Carcinoma
• Hormone Receptor-Positive Breast Carcinoma

Intervention / Treatment

• Procedure: Biospecimen Collection
• Drug: Cyclophosphamide
• Drug: Doxorubicin
• Biological: Durvalumab
• Other: Genetic Testing
• Procedure: Mammography
• Drug: Paclitaxel
• Other: Quality-of-Life Assessment

Primary Outcome Measures

• Breast cancer event-free survival (BC-EFS) (Up to 10 years after completion of study treatment)
  Defined as the earliest occurrence of any of the following events: Local-regional or distant progression during neoadjuvant therapy or local/regional, or distant invasive breast tumor recurrence post-surgery, invasive ipsilateral breast tumor recurrence, new invasive contralateral breast cancer, or death from any cause. The primary analysis of BC-EFS is a log-rank test between the treatment arms with stratification by the three stratification factors. Additionally, Cox regression will be used to estimate the treatment hazard ratio and 95% confidence interval including the three stratification variables as terms in the model. Kaplan-Meier graphs will show BC-EFS descriptively over time and provide 5-year estimates and 95% confidence intervals. A forest plot will show whether the treatment effect varies over the stratification variables and other selected factors.

Countries

Puerto Rico, United States

Locations and Investigators

• University of Alabama at Birmingham Cancer Center, Birmingham, United States (Recruiting)
  • Site Public Contact
  • Mauricio R. Escobar (Principal Investigator)
• Katmai Oncology Group, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Charles W. Drescher (Principal Investigator)
• University of Arizona Cancer Center-Orange Grove Campus, Tucson, United States (Recruiting)
  • Site Public Contact
  • Sima Ehsani Chimeh (Principal Investigator)
• Banner University Medical Center - Tucson, Tucson, United States (Recruiting)
  • Site Public Contact
  • Sima Ehsani Chimeh (Principal Investigator)
• University of Arizona Cancer Center-North Campus, Tucson, United States (Recruiting)
  • Site Public Contact
  • Sima Ehsani Chimeh (Principal Investigator)
• Mercy Hospital Fort Smith, Fort Smith, United States (Recruiting)
  • Site Public Contact
  • Jay W. Carlson (Principal Investigator)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, United States (Recruiting)
  • Site Public Contact
  • Ryan A. Yates (Principal Investigator)
• University of Arkansas for Medical Sciences, Little Rock, United States (Recruiting)
  • Site Public Contact
  • Sindhu Malapati (Principal Investigator)
• Sutter Auburn Faith Hospital, Auburn, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, United States (Recruiting)
  • Site Public Contact
  • Nicole Gordon (Principal Investigator)
• Alta Bates Summit Medical Center-Herrick Campus, Berkeley, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Tower Cancer Research Foundation, Beverly Hills, United States (Recruiting)
  • Site Public Contact
  • Jin Sun L. Bitar (Principal Investigator)
• City of Hope Comprehensive Cancer Center, Duarte, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• Palo Alto Medical Foundation-Fremont, Fremont, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, United States (Recruiting)
  • Site Public Contact
  • Ritesh Parajuli (Principal Investigator)
• City of Hope at Irvine Lennar, Irvine, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• City of Hope Antelope Valley, Lancaster, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• Loma Linda University Medical Center, Loma Linda, United States (Recruiting)
  • Site Public Contact
  • Ami N. Patel (Principal Investigator)
• City of Hope at Long Beach Elm, Long Beach, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles, United States (Recruiting)
  • Site Public Contact
  • Jin Sun L. Bitar (Principal Investigator)
• Cedars-Sinai Medical Center, Los Angeles, United States (Recruiting)
  • Site Public Contact
  • Jin Sun L. Bitar (Principal Investigator)
• Memorial Medical Center, Modesto, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• City of Hope Newport Beach, Newport Beach, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, United States (Recruiting)
  • Site Public Contact
  • Ritesh Parajuli (Principal Investigator)
• Desert Regional Medical Center, Palm Springs, United States (Recruiting)
  • Site Public Contact
  • Soe T. Maunglay (Principal Investigator)
• Palo Alto Medical Foundation Health Care, Palo Alto, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Huntington Memorial Hospital, Pasadena, United States (Recruiting)
  • Site Public Contact
  • Jin Sun L. Bitar (Principal Investigator)
• Sutter Roseville Medical Center, Roseville, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Sutter Medical Center Sacramento, Sacramento, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• SWOG, Sacramento, United States (Recruiting)
  • Erin F. Cobain
  • Erin F. Cobain (Principal Investigator)
• Zuckerberg San Francisco General Hospital, San Francisco, United States (Active not recruiting)
• California Pacific Medical Center-Pacific Campus, San Francisco, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Mills Health Center, San Mateo, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Saint John's Cancer Institute, Santa Monica, United States (Recruiting)
  • Site Public Contact
  • Parvin F. Peddi (Principal Investigator)
• Providence Medical Foundation - Santa Rosa, Santa Rosa, United States (Recruiting)
  • Site Public Contact
  • Charles W. Drescher (Principal Investigator)
• Sutter Pacific Medical Foundation, Santa Rosa, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Providence Santa Rosa Memorial Hospital, Santa Rosa, United States (Recruiting)
  • Site Public Contact
  • Charles W. Drescher (Principal Investigator)
• City of Hope South Pasadena, South Pasadena, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• Cedars-Sinai Cancer - Tarzana, Tarzana, United States (Recruiting)
  • Site Public Contact
  • Jin Sun L. Bitar (Principal Investigator)
• City of Hope South Bay, Torrance, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• Torrance Memorial Physician Network - Cancer Care, Torrance, United States (Recruiting)
  • Site Public Contact
  • Jin Sun L. Bitar (Principal Investigator)
• City of Hope Upland, Upland, United States (Recruiting)
  • Site Public Contact
  • Irene M. Kang (Principal Investigator)
• Sutter Solano Medical Center/Cancer Center, Vallejo, United States (Recruiting)
  • Site Public Contact
  • Kristie A. Bobolis (Principal Investigator)
• UCI Health - Yorba Linda, Yorba Linda, United States (Recruiting)
  • Site Public Contact
  • Ritesh Parajuli (Principal Investigator)
• UCHealth University of Colorado Hospital, Aurora, United States (Recruiting)
  • Site Public Contact
  • Anthony D. Elias (Principal Investigator)
• UCHealth - Cherry Creek, Denver, United States (Recruiting)
  • Site Public Contact
  • Anthony D. Elias (Principal Investigator)
• Shaw Cancer Center, Edwards, United States (Recruiting)
  • Site Public Contact
  • Alexander T. Urquhart (Principal Investigator)
• Poudre Valley Hospital, Fort Collins, United States (Recruiting)
  • Site Public Contact
  • Anthony D. Elias (Principal Investigator)

And 513 other sites.

Study Officials

• Erin F Cobain (Principal Investigator) — SWOG Cancer Research Network