NCT03329378

Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75mg/m2 IV, day 1
DRUG	Carboplatin	Carboplatin AUC 6 IV, day 1
DRUG	Trastuzumab	Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
DRUG	Pertuzumab	Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
DRUG	Pegfilgrastim	Pegfilgrastim 6mg SC, day 2 Cycled as per arm
DRUG	Trastuzumab	Trastuzumab 6mg/kg every 21 days to complete 1 year
DRUG	Paclitaxel	Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
DRUG	Doxorubicin	Doxorubicin 60 mg/m2 IV day 1
DRUG	Cyclophosphamide	Cyclophosphamide 600 mg/m2 IV day 1
DRUG	Paclitaxel	80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15

Timeline

• Start date: 2019-01-24
• Primary completion: 2021-03-07
• Completion: 2021-03-07
• First posted: 2017-11-06
• Last updated: 2023-08-22
• Results posted: 2023-08-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study