Alternative Drug Names:
Keytruda is the brand name for Pembrolizumab. It used to be called MK-3475
Purpose of Trial:
This trial is testing the concept that activating the immune system in patients who had residual alive cancer at mastectomy will reduce recurrence more than standard endocrine therapy alone.
Why this study is relevant for IBC patients:
In IBC, the presence of residual cancer after chemotherapy in the mastectomy sample increases the likelihood of recurrence. Historical data has revealed that within 2 years, 40% of patients with ER+ IBC and residual disease will recur. The standard of care for patients with ER+ or PR+ IBC after chemo, surgery and radiation is hormonal/endocrine therapy i.e. either tamoxifen or aromatase inhibitors. This trial adds Pembrolizumab to this standard of care.
Pembrolizumab targets PD-1, which is a protein on the surface of T cells (a type of white blood cell), which functions to keep the T cells inactive. By removing this brake, the drug allows the T cells to help target any microscopic circulating cancer that is left over. Tumors including IBC find ways to evade the immune system that include interacting with PD-1.
This is a single arm phase 2 study, where all patients receive the real drug (no placebo). Patients with stage 3 IBC that is ER+ (10% or more) or PR+ and HER2- may be eligible. The trial is intended to be initiated within 6 months of beginning endocrine therapy (which is after the completion of radiation). Standard lab tests for organ function and blood cell counts must be within reasonable limits (see clinicaltrials.gov for details).
Keytruda is a liquid given by vein every 3 weeks for up to 2 years if you remain free of recurrence. The infusion is short (30 minutes). Endocrine therapy is a pill you will take every day for 5-10 years. Your oncologist will decide which type of endocrine therapy to give you based on your menopausal status among other factors. To participate in this investigator-initiated study, you will need to travel to MD Anderson every 3 weeks. At each visit you will have a physical exam, and blood draw prior to receiving the infusion – then you will be able to go home. You may continue as long as you are benefiting from treatment i.e. tolerating it well without signs of recurrence. After completing the study, you will receive a phone call from the research team to document any lasting problems.
Location of Trial:
Only at MD Anderson in Houston, TX (NCI Comprehensive Cancer Center)
For more information:
Is this study NCI Compliant?:
NCT trial number & link:
NCT02971748 click for more info
Poster from scientific meeting: