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NCT03128619 · ClinicalTrials.gov registry record · Phase 1
Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03128619: Clinical Trial Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT03128619 is a Phase 1 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03128619, a Phase 1 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole, and palbociclib may work better in treating patients with breast cancer.
Primary Outcome
Will be evaluated on the log Ki-67 ratio scale. Primary analysis of this variable will utilize a linear model with treatment, PR status as fixed effects. The comparison of treatment arms will be based on the least squares mean (LSM) estimates and standard errors derived from this model. For descriptive purposes, LSM estimates and associated confidence intervals (CIs) will be back transformed to the geometric mean percent change scale. A second post-baseline evaluation of Ki67 expression will be
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Letrozole
- DRUG Palbociclib
- PROCEDURE Biopsy of Breast
- DRUG Copanlisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 1 |
Why NCT03128619 stopped before completion
NCT03128619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03128619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03128619 about?
NCT03128619 is a clinical study titled "Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer". This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the growth of tumor cells by block...
What is the current status of trial NCT03128619?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-08-02. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT03128619?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Letrozole (DRUG), Palbociclib (DRUG), Biopsy of Breast (PROCEDURE), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT03128619?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03128619's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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