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NCT02139358 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02139358: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02139358 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02139358, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.
Primary Outcome
The RP2D dose in mg/m\^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.
Interventions
- DRUG Trastuzumab
- DRUG Gemcitabine
- DRUG Pertuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-09-05 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 1 |
What the finished NCT02139358 record still lists
NCT02139358 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT02139358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02139358 about?
NCT02139358 is a clinical study titled "Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer". The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T...
What is the current status of trial NCT02139358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-09-05. Estimated completion is 2020-03-16.
What interventions are being tested in trial NCT02139358?
The interventions under investigation include: Trastuzumab (DRUG), Gemcitabine (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT02139358?
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 NCT02139358's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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