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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy | Drug | Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| RCB scores | To compare the distribution of RCB scores and nodal clearance rates between the two treatment groups and across the two molecular subtypes. | 21 months |
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Inclusion Criteria:
Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Mount Hood Medical Center | Recruiting | Gresham | Oregon | 97030 | United States |
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| Legacy Good Samaritan Medical Center | Recruiting | Portland | Oregon | 97210 | United States |
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| Legacy Meridian Park Medical Center | Recruiting | Tualatin | Oregon | 97062 | United States |
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| Legacy Salmon Creek Medical Center | Recruiting | Vancouver | Washington | 98686 | United States |
|