Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Breast Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Part 1: 3+3 dose escalation of HCQ combined with abemaciclib in advanced solid tumors. Part 2: HCQ at top-dose level from part one is combined with abemaciclib and endocrine therapy in HR+/Her 2- advanced breast cancer (ABC) and divided into two cohorts based on prior exposure to endocrine therapy. ...
Part 1: 3+3 dose escalation of HCQ combined with abemaciclib in advanced solid tumors. Part 2: HCQ at top-dose level from part one is combined with abemaciclib and endocrine therapy in HR+/Her 2- advanced breast cancer (ABC) and divided into two cohorts based on prior exposure to endocrine therapy. Primary Objective Dose-escalation cohort: To determine safety and tolerability of HCQ combined with abemaciclib. Dose-expansion cohort: To determine safety and tolerability of HCQ combined with abemaciclib and endocrine therapy in HR+/Her2- ABC. Secondary Objectives To assess the clinical efficacy of HCQ in combination with abemaciclib and hormone blockade in the dose- expansion cohort of advanced ER- positive breast cancer participants. To assess the clinical efficacy of HCQ in combination with abemaciclib in the dose- escalation cohort
Tracking Information
- NCT #
- NCT04316169
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Smitha Menon, MD Medical College of Wisconsin
Get Well Soon