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

NCT04316169 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-12-23

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Smitha Menon, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316169 on ClinicalTrials.gov