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Hydroxychloroquine + Everolimus for Breast Cancer
Phase 2
Waitlist Available
Led By Angela DeMichele, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 2
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing if giving hydroxychloroquine, elesclomol, or a combination of the two drugs to people who have finished primary therapy for breast cancer and have bone marrow disseminated tumor cells is feasible.
Who is the study for?
This trial is for adults over 18 who've finished primary breast cancer therapy, have no signs of recurrence, and show bone marrow tumor cells. They must be healthy enough with good organ function and not pregnant or on other trials. Prior mTOR inhibitor treatment or hypersensitivity to Everolimus disqualifies them.Check my eligibility
What is being tested?
The CLEVER Pilot Trial tests Hydroxychloroquine (HCQ), Everolimus (EVE), or their combination in preventing recurrent breast cancer in patients with residual disease indicators after primary therapy.See study design
What are the potential side effects?
Possible side effects include issues affecting the liver, kidneys, blood cells, cholesterol levels, potential drug sensitivity reactions, and increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk and care for myself, but I am unable to do any work.
Select...
I am 18 years old or older.
Select...
I show no signs of breast cancer coming back, based on exams, blood tests, or imaging.
Select...
I still have cancer in my breast after chemotherapy before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Side effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
Trial Design
4Treatment groups
Experimental Treatment
Group I: observation (Arm D)Experimental Treatment2 Interventions
Group II: combination HCQ and EVE (Arm C)Experimental Treatment2 Interventions
Group III: HCQ alone (Arm A)Experimental Treatment1 Intervention
Group IV: EVE alone (Arm B)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Hydroxychloroquine
2017
Completed Phase 4
~5360
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,641 Total Patients Enrolled
45 Trials studying Breast Cancer
60,849 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,041 Total Patients Enrolled
42 Trials studying Breast Cancer
35,333 Patients Enrolled for Breast Cancer
Angela DeMichele, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
8 Previous Clinical Trials
11,138 Total Patients Enrolled
7 Trials studying Breast Cancer
10,538 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have health issues that prevent me from taking study drugs.I have not received any live vaccines within a week before or during the study.I am not pregnant, breastfeeding, and I use effective birth control.Tests show that there are cancer cells in the bone marrow after treatment.I have been treated with an mTOR inhibitor before.I am currently taking hormone therapy and bone-strengthening medications as part of my treatment.You are allergic to Everolimus or similar medications.My breast cancer was confirmed by a biopsy and diagnosed within the last 5 years.I can walk and care for myself, but I am unable to do any work.My blood, liver, kidneys, and cholesterol levels are all within healthy ranges.I finished my main cancer treatment at least 4 weeks ago.I am 18 years old or older.I show no signs of breast cancer coming back, based on exams, blood tests, or imaging.You have the specific risk status according to the ASCO/CAP guidelines for receptor testing.I am on a long-term, high dose of corticosteroid medication.I still have cancer in my breast after chemotherapy before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: HCQ alone (Arm A)
- Group 2: EVE alone (Arm B)
- Group 3: observation (Arm D)
- Group 4: combination HCQ and EVE (Arm C)
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 individuals are being trialed with this medication?
"That is correct, the study detailed on clinicaltrials.gov is currently looking for volunteers. This trial was first posted on January 23rd, 2017 and was last updated on June 8th of this year. They are hoping to enroll 60 individuals at a single site."
Answered by AI
Are new participants still being taken in for this research project?
"Yes, this information is available on clinicaltrials.gov. The trial was posted on 1/23/2017 and was edited on 6/8/2022, meaning that it is still actively recruiting patients."
Answered by AI
Is it risky to take Hydroxychloroquine?
"While there is some evidence to Hydroxychloroquine's safety, it scores a 2 because this is only based off data from Phase 2 trials which lack efficacy data."
Answered by AI
What other indications does Hydroxychloroquine have, outside of its original purpose?
"Hydroxychloroquine can be used to treat rejection in transplanted organs such as the liver. It can also help patients with waldenstrom macroglobulinemia, lung cancer, and kidney transplant rejections."
Answered by AI
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