Breast Cancer - Infiltrating Ductal Carcinoma, HER-2 Positive Breast Cancer
Conditions
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
Interventions
DRUGConcurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Sponsors
Legacy Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR Rates | 21 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RCB scores | 21 months | To compare the distribution of RCB scores and nodal clearance rates between the two treatment groups and across the two molecular subtypes. |
Countries
United States
Outcome results
None listed