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NCT07506876PHASE2Recruiting

Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer

Legacy Health System

Start Date

4/27/2026

Completion Date

12/1/2027

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

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Conditions

Breast Cancer - Infiltrating Ductal CarcinomaHER-2 Positive Breast Cancer

Locations

Legacy Mount Hood Medical Center

Gresham, Oregon 97030

United States

Legacy Good Samaritan Medical Center

Portland, Oregon 97210

United States

Legacy Meridian Park Medical Center

Tualatin, Oregon 97062

United States

Legacy Salmon Creek Medical Center

Vancouver, Washington 98686

United States