Supporting Immunotherapy to Improve Chemotherapy for Stage II-III Breast Cancer

Recruiting · Phase 3 · Anatomic Stage II Breast Cancer AJCC v8 and related conditions · 43 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at adding an immunotherapy drug called durvalumab to standard chemotherapy for women with certain types of stage II-III breast cancer. The goal is to see if this combination can help improve outcomes for patients. The study focuses on those with hormone receptor positive and HER2 negative breast cancer who are at higher risk of recurrence. Researchers hope that adding durvalumab can help the immune system fight the cancer better.

This trial is in Phase 3, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include about 3,680 participants.

Who can join

This study is open to adults aged 18 and older, including men and women. Participants must have hormone receptor positive and HER2 negative breast cancer that is either stage II or III. Those with previous treatments or metastatic disease cannot join. The trial team will check to confirm eligibility.

Conditions

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

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will first undergo testing to determine their MammaPrint score. Based on the results, they will be placed into one of two treatment groups: one group will receive standard chemotherapy, while the other group will receive chemotherapy along with durvalumab. Everyone will receive either chemotherapy or chemotherapy plus the immunotherapy. Participants will also have regular testing and may need to provide blood or tissue samples.