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NCT03329378 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03329378: Clinical Trial Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03329378 is a Phase 2 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03329378, a Phase 2 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Primary Objective: • Determination of pathologic complete response (pCR) rates Secondary Objective: * Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and troponin. * Breast conservation rates * Overall survival Study Design * Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will be enrolled. * Patients will be stratified by ER/PR status. * They will be randomized to ddACTHP vs TCHP. * Initially, 17 patients will be randomly assigned to each treatment arm. * If 3 or fewer patients have a pCR, then that arm will be terminated and no further patients will be entered on that treatment arm. * If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients) will be randomized to that treatment arm. * If 11 or more patients out of 37 have a pCR, the treatment will be of interest for further study.
Primary Outcome
Pathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy.
Interventions
- DRUG Trastuzumab
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Pertuzumab
- DRUG Pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2021-03-07 |
| Phase | Phase 2 |
Why NCT03329378 stopped before completion
NCT03329378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT03329378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03329378 about?
NCT03329378 is a clinical study titled "Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer". Primary Objective: • Determination of pathologic complete response (pCR) rates Secondary Objective: * Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and troponin. * Breast conservation rates * Overall survival Study Design * Approximately 34-74 patients...
What is the current status of trial NCT03329378?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-01-24. Estimated completion is 2021-03-07.
What interventions are being tested in trial NCT03329378?
The interventions under investigation include: Trastuzumab (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Pertuzumab (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT03329378?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03329378's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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