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Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling

NCT03412643 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-03-06

No results posted yet for this study

Summary

This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing.

Conditions

Interventions

DRUG

Doxorubicin

60 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles

DRUG

Cyclophosphamide

600 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles

DRUG

Weekly Paclitaxel

80 mg/m2 IV weekly for 12 doses

DRUG

Trastuzumab

loading dose of 8 mg/kg IV; then 6 mg/kg IV every 3 weeks for Cycles 2-4

DRUG

Pertuzumab

loading dose of 840 mg IV; then 420 mg IV every 3 weeks for Cycles 2-4

DIAGNOSTIC_TEST

Celcuity CELx HSF

Prior to drug interventions 3, 4,and 5, the Celcuity CELx HSF diagnostic test will be conducted to assess HER2 signaling activity

Sponsors & Collaborators

  • Celcuity, LLC

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03412643 on ClinicalTrials.gov