Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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

Recruiting Locations

Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Contact:
Legacy Oncology Clinical Research
503-13-8199
oncologyresearch@lhs.org

Legacy Good Samaritan Medical Center
Portland, Oregon 97210
Contact:
Legacy Oncology Research
503-413-8199
oncologyresearch@lhs.org

Legacy Meridian Park Medical Center
Tualatin, Oregon 97062
Contact:
Legacy Oncology Clinical Research
503-413-8199
oncologyresearch@lhs.org

Legacy Salmon Creek Medical Center
Vancouver, Washington 98686
Contact:
Legacy Oncology Clinical Research
503-413-8199
oncologyresearch@lhs.org

More Details

Status
Recruiting
Sponsor
Legacy Health System

Study Contact