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NCT03032406 · ClinicalTrials.gov registry record · Phase 2
CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer
A Phase 2 study of Breast Cancer Stage IIB, sponsored by Abramson Cancer Center at Penn Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT03032406: Active Phase 2 study of Breast Cancer Stage IIB, sponsored by Abramson Cancer Center at Penn Medicine.
NCT03032406 is a Phase 2 study of Breast Cancer Stage IIB that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03032406, a Phase 2 study of Breast Cancer Stage IIB, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the feasibility of administering HCQ, EVE or the combination in patients who have completed primary therapy for breast cancer and harbor bone marrow disseminated tumor cells.
Primary Outcome
For the primary endpoint of feasibility, we employed ongoing Bayesian toxicity monitoring after every 3 participants completed cycle 6, assuming a Beta (1,2) prior, equivalent to one DLT observed in 3 treated participants. Early termination of a treatment arm for toxicity (non-feasibility) would occur if the posterior probability that the toxicity rate exceeds the target maximum of 30% was greater than 75%. Trial enrollment and conduct was significantly impacted by the COVID pandemic, including
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Hydroxychloroquine
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-01-23 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 2 |
What the registry record for NCT03032406 still lists
NCT03032406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Breast Cancer Stage IIB appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT03032406 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03032406 about?
NCT03032406 is a clinical study titled "CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer". To evaluate the feasibility of administering HCQ, EVE or the combination in patients who have completed primary therapy for breast cancer and harbor bone marrow disseminated tumor cells.
What is the current status of trial NCT03032406?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2017-01-23. Estimated completion is 2026-01-01.
What conditions does trial NCT03032406 study?
This clinical trial studies the following conditions: Breast Cancer Stage IIB.
What interventions are being tested in trial NCT03032406?
The interventions under investigation include: Everolimus (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT03032406?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03032406 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03032406's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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