Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer

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

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Key information

Conditions

Breast Cancer - Infiltrating Ductal Carcinoma HER-2 Positive Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Legacy Mount Hood Medical Center, Gresham, Oregon, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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
Choice of endocrine therapy will be determined by the treating and/or enrolling physician
Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP
Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy

Exclusion criteria

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

Treatment and study plan

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Drug

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Legacy Health System

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 2, 2026
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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