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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
Must not have
Immunization with attenuated live vaccines within one week of study entry or during study period
Pregnancy, breastfeeding, or inadequate birth control methods for adults of reproductive potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can walk and care for myself, but I am unable to do any work.
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I am 18 years old or older.
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I show no signs of breast cancer coming back, based on exams, blood tests, or imaging.
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I still have cancer in my breast after chemotherapy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received any live vaccines within a week before or during the study.
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I am not pregnant, breastfeeding, and I use effective birth control.
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I have been treated with an mTOR inhibitor before.
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I am on a long-term, high dose of corticosteroid medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
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%
Wolff-Parkinson-White syndrome
1%
Coronary artery occlusion
1%
Anaemia
1%
Leukopenia
1%
Lumbar spinal stenosis
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
413 Previous Clinical Trials
164,577 Total Patients Enrolled
46 Trials studying Breast Cancer
60,887 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,450 Total Patients Enrolled
41 Trials studying Breast Cancer
35,313 Patients Enrolled for Breast Cancer
Angela DeMichele, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
9 Previous Clinical Trials
11,338 Total Patients Enrolled
7 Trials studying Breast Cancer
10,538 Patients Enrolled for Breast Cancer

Media Library

Hydroxychloroquine Clinical Trial Eligibility Overview. Trial Name: NCT03032406 — Phase 2
Breast Cancer Research Study Groups: EVE alone (Arm B), HCQ alone (Arm A), combination HCQ and EVE (Arm C), observation (Arm D)
Breast Cancer Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT03032406 — Phase 2
Hydroxychloroquine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03032406 — Phase 2
~6 spots leftby Nov 2025
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