NCT06441890

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	80mg/m2 IV D1, 8, 15
DRUG	Nab-paclitaxel	125mg/m2 IV D1, 8, 15
DRUG	Docetaxel	75mg/m2 IV D1
DRUG	Trastuzumab	8mg/kg loading, then 6mg/kg IV/SQ D1
DRUG	Pertuzumab	840 mg loading, then 420mg IV/SQ D1

Timeline

• Start date: 2024-12-05
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-06-04
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study