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NCT03747120 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by University of Texas Southwestern Medical Center.

Active
Registry status
Phase 2
Development phase
138
Enrollment target
5
Study locations

NCT03747120 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 138 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT03747120, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
138 participants
Enrollment target
5
Study locations

Study Summary

A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are \> 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.

Conditions Studied

Breast Cancer HER2-positive Breast Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG Trastuzumab
  • DRUG Paclitaxel
  • DRUG Pertuzumab

Study Locations (5)

California

  • Cedars Sinai Medical Center - Los Angeles

Massachusetts

  • Massachusetts General Hospital - Boston

New Mexico

  • New Mexico Cancer Center - Albuquerque

Oregon

  • Providence Cancer Institute - Portland

Texas

  • UT Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2019-01-25
Est. Completion 2029-12
Phase Phase 2

Sponsor

University of Texas Southwestern Medical Center

837 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03747120

The ClinicalTrials.gov registry entry for NCT03747120 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT03747120 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Massachusetts, New Mexico.

Frequently Asked Questions

What is clinical trial NCT03747120 about?

NCT03747120 is a clinical study titled "Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]". A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrol...

What is the current status of trial NCT03747120?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2019-01-25. Estimated completion is 2029-12.

What conditions does trial NCT03747120 study?

This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer.

What interventions are being tested in trial NCT03747120?

The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG).

Who is sponsoring clinical trial NCT03747120?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03747120 being conducted?

This trial has 5 study locations across California, Massachusetts, New Mexico, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.