Phase 1 Study of Avasopasem Added to CDK 46 Inhibitor and Hormonal Therapy for Metastatic Hormone Receptor Positive Breast Cancer Progressing on First Line Treatment

What this Trial Is About

Researchers are evaluating the safety and potential effectiveness of adding avasopasem to existing treatment with a CDK 46 inhibitor and hormonal therapy in patients with metastatic hormone receptor positive breast cancer who have experienced disease progression. This phase 1 non-randomized trial focuses on women with this specific type of breast cancer that has progressed despite first-line treatment. The study aims to understand if avasopasem can improve outcomes when combined with current therapies. Participants will receive avasopasem alongside their ongoing CDK 46 inhibitor ribociclib or abemaciclib and hormonal therapy an aromatase inhibitor or fulvestrant. Treatment cycles last 28 days, and the study will assess the tumor response through CT scans of the chest, abdomen, and pelvis every two cycles. This trial does not include patients on palbociclib as their current CDK 46 inhibitor. The treatment phase is planned for up to four months. During the study, participants will undergo regular imaging to monitor tumor changes and assessments to track safety and tolerability of the combination treatment. Researchers will measure clinical benefits and monitor side effects throughout each 28-day cycle. Patients must meet specific health and organ function criteria and will be monitored closely for any adverse effects. Participation may last several months, with ongoing evaluations to understand treatment impact and safety.

Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy