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NCT02657343 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02657343: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT02657343 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02657343, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Participants that have breast cancer that has spread to other parts of the body, is positive for a protein called HER2, and has not responded to standard treatment. This research study is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a possible treatment for this diagnosis.
Primary Outcome
Standard 3+3 phase-I design will be utilized in this trial. Briefly, a minimum of 3 evaluable patients will be entered at first dose level (=300 mg ribociclib) and T-DM1 (3.6 mg/kg IV). If 1 out of the first 3 patients enrolled experiences a dose-limiting toxicity (DLT), 3 additional patients will be enrolled to that dose level. If no more than 1 patient in 6 experiences a DLT, dose escalation of ribociclib will continue to next dose-level. If 2 or more patients at any given dose level experienc
Interventions
- DRUG Trastuzumab
- DRUG T-DM1
- DRUG Fulvestrant
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
What the finished NCT02657343 record still lists
NCT02657343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT02657343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02657343 about?
NCT02657343 is a clinical study titled "An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.". Participants that have breast cancer that has spread to other parts of the body, is positive for a protein called HER2, and has not responded to standard treatment. This research study is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a possible treatment for ...
What is the current status of trial NCT02657343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2016-03-09. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT02657343?
The interventions under investigation include: Trastuzumab (DRUG), T-DM1 (DRUG), Fulvestrant (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT02657343?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02657343's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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