Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07506876

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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