Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

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 ce

Trial Details

NCT ID
NCT06058377
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Biospecimen Collection
  • Cyclophosphamide
  • Doxorubicin
  • Durvalumab
  • Genetic Testing
  • Mammography
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648

Key Eligibility Criteria

  • STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR)…
  • NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP …
  • STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer
  • NOTE: Participants with inflammatory breast cancer are eligible

For full eligibility, visit ClinicalTrials.gov.

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