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Not listed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT03412643

Public ClinicalTrials.gov record NCT03412643. 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.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 3:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03412643
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 2
Lead sponsor
NSABP Foundation Inc
Network
Enrollment
64 participants

Conditions and interventions

Interventions

Drug · Diagnostic Test

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
May 13, 2018
Primary completion
Oct 29, 2023
Completion
Oct 29, 2023
Last update posted
Mar 5, 2023

2018 – 2023

United States locations

U.S. sites
43
U.S. states
17
U.S. cities
37
Facility City State ZIP Site status
Arrowhead Regional Medical Center Colton California 92324 Recruiting
Mount Sinai Comprehensive Cancer Center Miami Beach Florida 33140 Recruiting
University of Florida Cancer Center at Orlando Health Orlando Florida 32806 Recruiting
Cancer Care Specialists of Central Illinois Decatur Illinois 62526 Recruiting
Edward Hospital Cancer Center Naperville Illinois 60540-7499 Recruiting
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana 46804 Recruiting
University of Iowa Iowa City Iowa 52242 Recruiting
University of Louisville JG Brown Cancer Center Louisville Kentucky 40202 Recruiting
University Medical Center New Orleans New Orleans Louisiana 70112 Recruiting
Greater Baltimore Medical Center Baltimore Maryland 21204 Recruiting
St. Joseph Mercy Hospital Ann Arbor Michigan 48106 Recruiting
Henry Ford Hospital Detroit Michigan 48202 Recruiting
Genesys Hurley Cancer Institute Flint Michigan 48503 Recruiting
Herbert Herman Cancer Center, Sparrow Hospital Lansing Michigan 48912 Recruiting
Ascension St. Mary's Saginaw Michigan 48601 Recruiting
Newark Beth Israel Medical Center Newark New Jersey 07112 Recruiting
University of Rochester - Wilmot Cancer Institute Rochester New York 14642 Recruiting
Strecker Cancer Center-Belpre Belpre Ohio 45714 Recruiting
Aultman Hospital Canton Ohio 44710 Recruiting
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195 Recruiting
Arthur G. James Cancer Hospital & Richard Solove Research Institute Columbus Ohio 43210 Recruiting
Columbus Oncology & Hematology Associates Inc Columbus Ohio 43214 Recruiting
The Mark H. Zangmeister Center Columbus Ohio 43219 Recruiting
Doctors Hospital Columbus Ohio 43228 Recruiting
Adena Regional Medical Center Columbus Ohio 45601 Recruiting
Dayton Clinical Oncology Program Dayton Ohio 45420 Recruiting
Dayton Physicians LLC Dayton Ohio 45420 Recruiting
Delaware Health Center Delaware Ohio 43015 Recruiting
Marietta Memorial Hospital Cancer Center Marietta Ohio 45750 Recruiting
Marion General Hospital Marion Ohio 43303 Recruiting
Knox Community Hospital Mount Vernon Ohio 43050 Recruiting
Licking Memorial Hospital Newark Ohio 43055 Recruiting
Southern Ohio Medical Center Portsmouth Ohio 45662 Recruiting
Genesis Health Care Zanesville Ohio 43701 Recruiting
Wellspan Health - York Cancer Center York Pennsylvania 17403 Recruiting
Harris Health Systems-Smith Clinic Houston Texas 77030 Recruiting
Lester and Sue Smith Breast Center Houston Texas 77030 Recruiting
Centra Lynchburg Hematology Oncology Lynchburg Virginia 24501 Recruiting
Bon Secours Richmond Community Hospital Medical Oncology Assoc. Mechanicsville Virginia 23116 Recruiting
Bon Secours St. Francis Medical Center Midlothian Virginia 23114 Recruiting
Bon Secours Richmond Community Hospital at St. Mary's Richmond Virginia 23226 Recruiting
West Virginia University Morgantown West Virginia 26506 Recruiting
Ascension St. Elizabeth Hospital Appleton Wisconsin 54915 Recruiting

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 NCT03412643, 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 Mar 5, 2023 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03412643 live on ClinicalTrials.gov.

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