About this trial

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.

Eligibility criteria

Qualifiers

STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines

NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible

STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer

NOTE: Participants with inflammatory breast cancer are eligible

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Cyclophosphamide
  • Doxorubicin
  • Durvalumab
  • Genetic Testing
  • Mammography
  • Paclitaxel
  • Quality-of-Life Assessment

Treatment groups

3,680 Participants
are divided into 3 treatment groups

Locations

543
Puerto Rico
Centro Comprensivo de Cancer de UPR00927, San Juan Puerto Rico
PROncology00927, San Juan Puerto Rico
United States
Alabama
University of Alabama at Birmingham Cancer Center35233, Birmingham United States
Alaska
Katmai Oncology Group99508, Anchorage United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor