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NCT03774472 · ClinicalTrials.gov registry record · Phase 1
Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer
A Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03774472: Completed Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03774472 is a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 305-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03774472, a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Incidence of adverse events (Phase I) \[Time Frame: Up to 30 days post-treatment\] Assessed continuously using Common Terminology Criteria for Adverse Events version 4.03, with physical examination and laboratory assessments.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Palbociclib
- DRUG Hydroxychloroquine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-08-20 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 1 |
What the finished NCT03774472 record still lists
NCT03774472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 305-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Letrozole is the first listed.
NCT03774472 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03774472 about?
NCT03774472 is a clinical study titled "Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer". 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...
What is the current status of trial NCT03774472?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-08-20. Estimated completion is 2024-04-17.
What conditions does trial NCT03774472 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8.
What interventions are being tested in trial NCT03774472?
The interventions under investigation include: Letrozole (DRUG), Palbociclib (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT03774472?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03774472 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03774472's enrollment target sits among peer trials
15 82nd of 84 higher than 2 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 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.
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