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NCT04108858 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04108858: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04108858 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04108858, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies the side effects and best dose of copanlisib when given together with trastuzumab and pertuzumab and to see how well they work after induction treatment in treating patients with HER2 positive stage IV breast cancer with PIK3CA or PTEN mutation. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may kill tumor cells that are left after chemotherapy. The addition of copanlisib to the usual treatment (trastuzumab and pertuzumab) could shrink the cancer or stabilize it for longer duration as compared to the usual treatment alone.
Primary Outcome
Incidence of adverse events and serious adverse events to determine safety: incidence of DLTs to determine RP2D
Interventions
- BIOLOGICAL Trastuzumab
- BIOLOGICAL Pertuzumab
- DRUG Copanlisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2022-04-29 |
| Phase | Phase 1 |
Why NCT04108858 stopped before completion
NCT04108858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT04108858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04108858 about?
NCT04108858 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer". This phase Ib/II trial studies the side effects and best dose of copanlisib when given together with trastuzumab and pertuzumab and to see how well they work after induction treatment in treating patients with HER2 positive stage IV breast cancer with PIK3CA or PTEN mutation. Copanlisib may stop the...
What is the current status of trial NCT04108858?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-05-20. Estimated completion is 2022-04-29.
What interventions are being tested in trial NCT04108858?
The interventions under investigation include: Trastuzumab (BIOLOGICAL), Pertuzumab (BIOLOGICAL), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT04108858?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04108858's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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