RecruitingPhase 2NCT07506876
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
Sponsor
Legacy Health System
Enrollment
30 participants
Start Date
Apr 27, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
DRUGConcurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07506876