A Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of a Folate Receptor Alpha Vaccine in Patients with Triple-Negative Breast Cancer.

ABSTRACT:

Purpose

CD4 T-cell immunity is associated with improved survival in patients with breast cancer. We previously reported a phase I trial evaluating a folate receptor alpha (FRα) vaccine administered with cyclophosphamide (CP), demonstrating excellent safety and immunogenicity. To simplify the vaccine strategy for ease of use, we report here the results of a randomized phase II trial evaluating a lower vaccine dose alongside the original dose, administered with or without CP pretreatment.

Patients and methods

Patients with triple-negative breast cancer who completed all systemic and local therapies were assigned to receive either low-dose (825 μg) or high-dose (2.5 mg) vaccine peptides plus GM-CSF in six 4-week cycles, with or without CP prior to vaccination. Safety was monito

SUBMITTER: Knutson KL 

PROVIDER: S-EPMC12770932 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature