CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Hydroxychloroquine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03774472
NCT03774472Phase 2Completed

Phase I/II Safety and Efficacy Study of Autophagy Inhibition With Hydroxychloroquine to Augment the Antiproliferative and Biological Effects of Pre-Operative Palbociclib Plus Letrozole for Estrogen Receptor-Positive and HER2-Negative Breast Cancer

M.D. Anderson Cancer Center·interventional·Posted Dec 13, 2018·Updated Feb 17, 2025

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine, Letrozole, and 1 other intervention for Anatomic Stage I Breast Cancer AJCC v8 and 20 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of hydroxychloroquine when given together with palbociclib and letrozole before surgery in treating patients with estrogen receptor positive, HER2 negative breast cancer. Hydroxychloroquine is a substance that decreases immune responses in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Giving hydroxychloroquine, palbociclib, and letrozole before surgery may work better than palbociclib and letrozole in treating patients with breast cancer.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 13, 2018
Enrollment StartAug 20, 2018
Primary CompletionApr 17, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 7.6 years ago

Interventions

Hydroxychloroquinedrug

Given PO

Letrozoledrug

Given PO

Palbociclibdrug

Given PO