Actively Recruiting
Concurrent Neoadjuvant Chemotherapy and Endocrine Therapy in Hormone Receptor Positive, HER2 Positive Breast Cancer
Led by Legacy Health System · Updated on 2026-05-01
30
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding endocrine therapy to the usual chemotherapy and HER2-targeted therapy before surgery can improve treatment response in adults with hormone receptor-positive, HER2-positive breast cancer. This phase 2 study focuses on breast cancer patients who have not yet received treatment and aims to see if this combination increases the effectiveness of therapy at the time of surgery. Participants will receive concurrent endocrine therapy along with chemotherapy and HER2-directed therapy as part of their treatment before surgery. The choice of endocrine therapy will be decided by their physician, and it must begin before the second cycle of chemotherapy and HER2 therapy. The study includes patients with stage IIA to IIIC breast cancer who will undergo at least four cycles of TCHP chemotherapy. During the study, researchers will monitor participants for pathological complete response rates 21 months after treatment begins and assess residual cancer burden scores as a secondary outcome. Participants will be followed over this period to evaluate their response to therapy. Safety and treatment effects will be observed throughout, with ongoing assessments to understand how well the combined therapies work together.
CONDITIONS
Brief Title
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years of age with newly diagnosed, previously untreated, hormone receptor-positive, HER2-positive breast cancer
- Endocrine therapy for current breast cancer may start within 28 days before enrollment and must begin before cycle 2 of chemotherapy/HER2 therapy
- Planned anatomic stage IIA to IIIC breast cancer with minimum of 4 cycles of TCHP chemotherapy
- Patients must be Luminal A, Luminal B, or HER2 enriched subtype based on MammaPrint/BluePrint testing on initial biopsy
You will not qualify if you...
- Children under 18 years of age, pregnant women, prisoners, and adults unable to make decisions
- Patients with non-breast cancer within the prior 2 years
- Patients with breast cancer within the prior 5 years
- Patients with recurrent breast cancer
- Patients with stage IV breast cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Minimum of 4 cycles of chemotherapy
Participants receive concurrent endocrine therapy with chemotherapy and HER2 directed therapy.
Visits coincide with chemotherapy cycles
Trial Site Locations
Total: 4 locations
1
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Actively Recruiting
2
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Actively Recruiting
3
Legacy Meridian Park Medical Center
Tualatin, Oregon, United States, 97062
Actively Recruiting
4
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States, 98686
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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