BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial
University of Illinois at Chicago
Summary
Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care
Description
Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care. Patients whose tumors have a HER2-enriched molecular subtype on the MammaPrint®/BluePrint® assay and are recommended for neoadjuvant chemotherapy by their treating Oncologist will be recruited for study enrollment
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years of age at time of consent * ECOG performance status 0, 1, or 2 * Histologically confirmed invasive breast cancer documented by core needle or surgical biopsy with 90 days prior to study registration. * HER2-positive by IHC or FISH according to ASCO/CAP 2018 guidelines * HER2-enriched subtype on the MammaPrint/BluePrint gene expression profile within 90 days prior to study registration. * Curative resection of primary breast tumor(s) is planned; ipsilateral axillary nodes will be sampled by sentinel lymph node biopsy or axillary dissection * Treating Oncolo…
Interventions
- DrugPaclitaxel
80mg/m2 IV D1, 8, 15
- DrugNab-paclitaxel
125mg/m2 IV D1, 8, 15
- DrugDocetaxel
75mg/m2 IV D1
- DrugTrastuzumab
8mg/kg loading, then 6mg/kg IV/SQ D1
- DrugPertuzumab
840 mg loading, then 420mg IV/SQ D1
Location
- University of IllinoisChicago, Illinois