Durvalumab with Chemotherapy for Stage II-III Breast Cancer

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

Recruiting Phase 3 Interventional Study
Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma Hormone Receptor-Positive Breast Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
3,680 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for women with hormone receptor positive, HER2 negative stage II-III breast cancer. Participants will receive standard chemotherapy along with an immunotherapy drug called durvalumab to see if it helps prevent cancer from coming back.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with hormone receptor positive, HER2 negative breast cancer.
  • I have clinical stage II or III breast cancer.
  • I am at least 18 years old.
  • I weigh more than 30 kg.
  • I have a Zubrod Performance Status of 0-2.
  • I have not received any prior treatment for my current breast cancer.

You may not be able to join if

  • I have inflammatory breast cancer.
  • I have metastatic disease.
  • I have had locally recurrent breast cancer.
  • I have had a recent history of non-infectious pneumonitis requiring steroids.
  • I have a history of active autoimmune disease requiring treatment.
  • I have a prior or concurrent malignancy that could affect the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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…
Contacts

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