Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer

NCT07506876 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 50876
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• pCR Rates

  To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes

  21 months

Secondary Outcomes (1)

• RCB scores

  21 months

Study Arms (1)

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

EXPERIMENTAL

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

Interventions

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy DRUG

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Legacy Health System: lead

Study Sites (4)

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

RECRUITING

Legacy Good Samaritan Medical Center

Portland, Oregon, 97210, United States

RECRUITING

Legacy Meridian Park Medical Center

Tualatin, Oregon, 97062, United States

RECRUITING

Legacy Salmon Creek Medical Center

Vancouver, Washington, 98686, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)