About this trial
This trial looks at shorter chemotherapy and immunotherapy options for people with early-stage triple negative breast cancer. It compares a treatment without anthracyclines to the usual treatment that includes them. The goal is to see if these shorter treatments are just as effective in keeping cancer from coming back and how they affect patients' quality of life.
The trial's ID number is NCT05929768. This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. It is FDA-regulated, and the study aims to include about 2400 participants.
Who can join
This study is open to adults aged 18 and older, both men and women. Participants must have a specific type of breast cancer that is negative for certain hormones. They should not have received any prior treatment for this cancer and must meet other health guidelines. The trial team will confirm each person's eligibility.
Conditions
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed in one of two groups. One group will receive the usual treatment with paclitaxel, carboplatin, and doxorubicin, along with pembrolizumab. The other group will get a shorter treatment with docetaxel, carboplatin, and pembrolizumab. Everyone will have surgery after their treatment, and some may provide blood samples for research.
Where
This trial is running at 955 locations in the United States. 915 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Adams Cancer Center
Gettysburg, Pennsylvania
Addison Gilbert Hospital
Gloucester, Massachusetts
AdventHealth Hendersonville
Hendersonville, North Carolina
AdventHealth Infusion Center Asheville
Asheville, North Carolina
AdventHealth Infusion Center Haywood
Clyde, North Carolina
AdventHealth Infusion Center Weaverville
Weaverville, North Carolina
AdventHealth Littleton
Littleton, Colorado
The first 8 of 955 sites are listed here. The registry record has the full list.