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NCT03112590 · ClinicalTrials.gov registry record · Phase 1
Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT03112590: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03112590 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03112590, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer. Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.
Primary Outcome
The dose limiting toxicity (DLT) evaluation period for dose escalation will be during the first three weeks. The maximum tolerated dose (MTD) dose level is defined as the highest dose level with ≤1 out of 6 participants experiencing a DLT. If the first dose level experience two or more DLTs, then dose de-escalation will occur. DLT during cycle one (C1) is defined as follows: Non-hematologic or hematologic toxicities that are ≥ grade 3 in severity and probably or definitely related to study thera
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- BIOLOGICAL Interferon-gamma (IFN-γ)
- OTHER Pertuzumab
- PROCEDURE Post Therapy Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2023-02-20 |
| Phase | Phase 1 |
What the finished NCT03112590 record still lists
NCT03112590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT03112590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03112590 about?
NCT03112590 is a clinical study titled "Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer". This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at ot...
What is the current status of trial NCT03112590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2017-06-23. Estimated completion is 2023-02-20.
What interventions are being tested in trial NCT03112590?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Interferon-gamma (IFN-γ) (BIOLOGICAL), Pertuzumab (OTHER), Post Therapy Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03112590?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03112590's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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