Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03329378
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Terminated
Phase	Phase 2
Start date	January 24, 2019
Completion date	March 7, 2021

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