Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer
Public ClinicalTrials.gov record NCT03329378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized Trial Evaluating Neoadjuvant Dose-Dense Doxorubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab/Pertuzumab (AC THP) and Docetaxel/Carboplatin/Trastuzumab/Pertuzumab (TCHP) For Early Her2Neu Positive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03329378
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 7 participants
Conditions and interventions
Conditions
Interventions
- Docetaxel Drug
- Carboplatin Drug
- Trastuzumab Drug
- Pertuzumab Drug
- Pegfilgrastim Drug
- Paclitaxel Drug
- Doxorubicin Drug
- Cyclophosphamide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2019
- Primary completion
- Mar 6, 2021
- Completion
- Mar 6, 2021
- Last update posted
- Aug 21, 2023
2019 – 2021
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mount Sinai Beth Israel | New York | New York | 10011 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03329378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2023 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03329378 live on ClinicalTrials.gov.