Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer

April 27, 2026 updated by: Nathalie Johnson, Legacy Health System

The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.

The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • Legacy Mount Hood Medical Center
        • Contact:
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Medical Center
        • Contact:
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Medical Center
        • Contact:
    • Washington
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)

    1. Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy/HER2 directed therapy
    2. Choice of endocrine therapy will be determined by the treating and/or enrolling physician
  2. Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP
  3. Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy

Exclusion Criteria:

  1. Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.
  2. Patients with non-breast cancer within prior 2 years
  3. Patients with breast cancer within prior 5 years
  4. Patients with recurrent breast cancer
  5. Patients with stage IV breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Drug: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR Rates
Time Frame: 21 months
To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes
21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RCB scores
Time Frame: 21 months
To compare the distribution of RCB scores and nodal clearance rates between the two treatment groups and across the two molecular subtypes.
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Legacy Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 50876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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