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
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