Title: Phase 1 dose-escalation, dose-expansion trial of intratumoral HER2- and HER3-primed dendritic cell injections for the treatment of early-stage TNBC and ER low positive breast cancer (DecipHER)
Principal Investigator: Ricardo, Costa, MD, of Moffitt Cancer Center in Tampa, Florida
Description: Researchers are conducting a phase 1 study to test dendritic cell (DC) vaccination in combination with standard of care chemotherapy in patients with triple-negative breast cancer (TNBC) or hormone receptor (HR)-low breast cancer.
Patients will receive alternating intratumoral injections, 3 days apart, of HER2-primed DCs, followed by HER3-primed DCs.
The cell doses will be escalated if toxicity is deemed acceptable. The 3 planned dose levels are 10-20 million DCs, 30-50 million DCs, and 80-100 million DCs.
The primary outcome is the maximum tolerated dose. Secondary outcome measures include the number of dose-limiting toxicities, pathological complete response rate, and recurrence-free survival.
To be eligible for this study, patients must be 18 years of age and older. They must have a diagnosis of TNBC or HER2-negative/HR-low breast cancer. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Moffitt Cancer Center and the Shula Fund.
ClinicalTrials.gov. DecipHER trial – DC1 tx for early-stage TNBC and ER low positive breast cancer (DecipHER). NCT05504707. Accessed September 19, 2022.