Phase 1b trial investigates safety and efficacy of pegylated liposomal doxorubicin and pembrolizumab in ER-positive metastatic breast cancer, indicating potential benefits.
Key Points
This study aims to evaluate the safety and efficacy of pegylated liposomal doxorubicin combined with pembrolizumab in treating estrogen receptor positive metastatic breast cancer.
Phase 1b study design with two cohorts: PLD at 30 mg/m2 Q3W and 40 mg/m2 Q4W with pembrolizumab 200 mg Q3W.
Eligibility included patients with metastatic breast cancer who had progressed on previous treatments.
Outcomes assessed included safety, response rates, survival, and pharmacokinetics of PLD and pembrolizumab.
The disease control rate was 67%, with a median response duration of 11 months.
Median overall survival of patients was 25 months.
Treatment was generally well tolerated, with minimal serious adverse events and no significant neutropenia.