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Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

NCT03329378 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-08-22

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Aarti Bhardwaj, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2021-03-07
Completion
2021-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329378 on ClinicalTrials.gov