Recruiting
Phase 2

Endocrine Therapy with Chemotherapy & HER2 Directed Therapy

Sponsor:

Legacy Health System

Code:

NCT07506876

Conditions

Breast Cancer - Infiltrating Ductal Carcinoma

HER-2 Positive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Study Details

Brief 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

Conditions

Breast Cancer - Infiltrating Ductal Carcinoma

HER-2 Positive Breast Cancer

Study ID

NCT07506876

Start date

Apr 27, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Interventions

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Primary outcome measure

  • pCR Rates [ Time Frame: 21 months ]

Central Contacts and Locations

Locations

Legacy Mount Hood Medical Center

Recruiting

Gresham, Oregon, United States, 97030

Contacts

Legacy Oncology Clinical Research

503-13-8199oncologyresearch@lhs.org

Legacy Good Samaritan Medical Center

Recruiting

Portland, Oregon, United States, 97210

Contacts

Legacy Meridian Park Medical Center

Recruiting

Tualatin, Oregon, United States, 97062

Contacts

Legacy Oncology Clinical Research

503-413-8199oncologyresearch@lhs.org

Legacy Salmon Creek Medical Center

Recruiting

Vancouver, Washington, United States, 98686

Contacts

Legacy Oncology Clinical Research

503-413-8199oncologyresearch@lhs.org

More Information

Sponsor

Legacy Health System

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Legacy Health System on 2026-05-01.