NCT04316169

Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer

Hydroxychloroquine (HCQ) in Combination With Abemaciclib and Endocrine Therapy in HR+/Her 2- Advanced Breast Cancer After a Lead in Dose Escalation Cohort of HCQ and Abemaciclib in Advanced Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis is that abemaciclib synergizes with autophagy inhibitor hydroxychloroquine (HCQ/ Plaquenil), inducing apoptosis leading to tumor regression.

Detailed 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. Primary Objective 1. Dose-escalation cohort: To determine safety and tolerability of HCQ combined with abemaciclib. 2. Dose-expansion cohort: To determine safety and tolerability of HCQ combined with abemaciclib and endocrine therapy in HR+/Her2- ABC. Secondary Objectives 1. 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. 2. To assess the clinical efficacy of HCQ in combination with abemaciclib in the dose- escalation cohort

Conditions

• Solid Tumor
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Abemaciclib	150 mg b.i.d
DRUG	Hydroxychloroquine 200 mg	Dose level: 200 mg b.i.d.
DRUG	Faslodex	Cohort B will receive Faslodex.
DRUG	Anastrazole	Cohort A will receive anastrazole or letrozole.
DRUG	Letrozole	Cohort A will receive anastrazole or letrozole.
DRUG	Hydroxychloroquine 400 mg	Dose level: 400 mg. b.i.d.
DRUG	Hydroxychloroquine 600 mg	Dose level: 600 mg b.i.d.

Timeline

• Start date: 2021-10-21
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2020-03-20
• Last updated: 2022-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study