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Autophagy Inhibitor
Triple Therapy for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Debasish Tripathy
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of estrogen positive breast cancer, estrogen receptor-positive and HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria
Neoadjuvant cohorts (Phase II): Diagnosis of stage I-III estrogen positive breast cancer, estrogen receptor-positive and HER2-negative by ASCO/CAP criteria. If stage I, clinical tumor size must be >= 1.5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing the side effects and best dosage of hydroxychloroquine when given with two other drugs before surgery, in treating patients with a certain type of breast cancer.
Who is the study for?
This trial is for postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer. Participants must have a certain level of blood cells and organ function, be candidates for surgery and pre-operative endocrine therapy (Phase II), or suitable for CDK4/6 inhibitor treatment (Phase I). Exclusions include retinal disease, short life expectancy, recent use of specific drugs, other medical conditions that affect study compliance, pregnancy, prior breast cancer treatments (Phase II), inoperable/metastatic cancer (Phase II), and previous CDK 4/6 inhibitors.Check my eligibility
What is being tested?
The trial tests the combination of hydroxychloroquine with palbociclib and letrozole before surgery to see if it's more effective than just palbociclib and letrozole. Hydroxychloroquine may reduce immune responses; palbociclib blocks enzymes needed by tumor cells; letrozole decreases estrogen production which can fuel breast cancer growth.See study design
What are the potential side effects?
Potential side effects include visual disturbances due to hydroxychloroquine's impact on the retina. Palbociclib might cause low white blood cell counts leading to infection risk. Letrozole could result in bone thinning or joint pain due to reduced estrogen levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is estrogen positive and HER2 negative.
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My breast cancer is early stage, estrogen positive, and HER2 negative.
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My breast cancer is stage IV, estrogen positive, and HER2 negative.
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I have not taken CDK 4/6 inhibitors for my metastatic condition.
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I am fully active or can carry out light work.
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I am postmenopausal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in autophagy (Phase II, Part I)
Change in breast tumor proliferation index (Ki67) (Phase II, Part I)
Change in cell cycle control (Phase II, Part I)
+3 moreSecondary outcome measures
Blood-based tumor protein, deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) biomarkers (Phase II Part I and II)
Breast tumor indices of proliferation, autophagy, senescence, cell cycle control and other intersecting pathways (Phase II Part II)
Dose responsiveness hydroxychloroquine (400 mg versus recommended phase 2 dose) (Phase II Part II)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (hydroxychloroquine, palbociclib, letrozole)Experimental Treatment3 Interventions
PHASE I: Patients with advanced, metastatic (stage IV) breast cancer receive hydroxychloroquine PO QD, palbociclib PO QD, and letrozole PO QD on days 1-28. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients with early stage (stage I-III) breast cancer receive hydroxychloroquine PO QD on days 15-28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive palbociclib PO QD, and letrozole PO QD on days 1-28, followed by standard of care surgery at week 5. If there is a proliferative benefit with CCCA by biopsy at 4 weeks, cycles may repeat every 28 days for up to 20-24 weeks in the absence of disease progression or unacceptable toxicity, followed by standard of care surgery during weeks 20-24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360
Letrozole
2002
Completed Phase 4
~3240
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,306 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Debasish TripathyPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have enough white blood cells called neutrophils.I am eligible for treatment with CDK4/6 inhibitors and hormonal therapy.If you have a specific marker called Ki67 in your tumor that is higher than 5%.My cancer is large or has spread to nearby tissues.Your blood creatinine level is within a certain range.I have had treatment for breast cancer before.You are not expected to live for more than 6 months.My breast cancer cannot be removed by surgery or has spread.My breast cancer is estrogen positive and HER2 negative.Your personal, family, social, or living situation makes it difficult for you to follow the study rules.I am eligible for surgery and can receive hormone therapy before surgery.Your liver enzymes AST and ALT should be within three times the upper limit of normal.My breast cancer is early stage, estrogen positive, and HER2 negative.I do not have a history of retinal disease or current vision problems.I haven't taken certain medications in the last 4 weeks.I do not have any current infections, bleeding disorders, or need for blood thinners.Your platelet count is at least 100,000 per microliter.My breast cancer is stage IV, estrogen positive, and HER2 negative.Your bilirubin level is lower than 1.5 times the upper limit of normal.Your alkaline phosphatase blood test result is within a certain range.I am currently taking medication that strongly affects liver enzyme activity.I have not taken CDK 4/6 inhibitors for my metastatic condition.I have been treated with CDK 4/6 inhibitors before.I am fully active or can carry out light work.I am postmenopausal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hydroxychloroquine, palbociclib, letrozole)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this trial thus far?
"This trial is no longer accepting applications. It was first posted on August 20th 2018 and the last update took place September 30th 2022. In case of further inquiry, there are presently 2287 trials for breast cancer and 315 studies recruiting patients that may be suitable to receive Palbociclib."
Answered by AI
Is the recruitment period for this experiment still ongoing?
"This trial is no longer taking on new patients. It was initially published on August 20th 2018, and its last update occurred on September 30th 2022. For individuals looking for other studies, there are presently 2287 trials dealing with breast cancer and 315 clinical trials recruiting participants to test Palbociclib's efficacy."
Answered by AI
Is Palbociclib's efficacy supported by prior research?
"Currently, 315 investigations in the process of studying Palbociclib. Among these active studies, 55 are at Phase 3. Majority of trials for this drug take place in Shanghai; however, there are 15870 sites around the globe currently running tests with this medicine."
Answered by AI
What clinical conditions is Palbociclib typically used to treat?
"Palbociclib has proven efficacy at treating q fever, as well as tamoxifen, malaria and sjögren's syndrome."
Answered by AI
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