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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03329378
The ClinicalTrials.gov registry entry for NCT03329378 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT03329378 reports 0 study locations.
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.
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