The phase 2 BRE-10 INNOVATE trial is actively recruiting adults with IHC/FISH-confirmed HER2-positive early-stage breast cancer to evaluate whether MammaPrint®/BluePrint® genomic profiling can optimize neoadjuvant chemotherapy and HER2-targeted regimen selection. The interventional study is led by the University of Illinois at Chicago.

The BRE-10 INNOVATE trial (NCT06441890) is a phase 2 interventional study currently recruiting adult men and women diagnosed with early-stage, IHC/FISH-confirmed HER2-positive breast cancer. The trial is designed to assess whether upfront genomic biomarker profiling—using the MammaPrint® and BluePrint® assays performed on diagnostic biopsy specimens—can meaningfully guide the selection and optimization of neoadjuvant systemic therapy.

Neoadjuvant regimens under investigation incorporate taxane-based chemotherapy agents—paclitaxel, nab-paclitaxel, and docetaxel—in combination with the HER2-directed monoclonal antibodies trastuzumab and pertuzumab. This dual HER2 blockade backbone reflects current standard-of-care frameworks, while the biomarker-stratification layer aims to refine which patients derive the greatest benefit from specific regimen configurations prior to surgery.

MammaPrint® provides a binary low/high genomic risk classification, while BluePrint® characterizes molecular subtype beyond IHC-based receptor status—potentially reclassifying tumors that are HER2-positive by conventional testing into distinct functional subtypes. The INNOVATE trial seeks to determine whether this molecular reclassification has actionable implications for neoadjuvant decision-making in the HER2-positive population, where pathologic complete response rates and long-term outcomes remain heterogeneous despite dual anti-HER2 therapy.

The trial is investigator-initiated at the University of Illinois at Chicago. Full eligibility criteria, primary endpoints, and biomarker-stratification schema have not been detailed in the available registry data, and further protocol specifics should be sought directly from the trial registry or coordinating site.

Key points

  • Phase 2 INNOVATE trial (BRE-10/NCT06441890) is actively recruiting adults with IHC/FISH-confirmed HER2-positive early-stage breast cancer
  • MammaPrint® and BluePrint® genomic assays are performed on diagnostic biopsy specimens as part of standard oncologic workup to guide neoadjuvant regimen selection
  • Neoadjuvant regimens combine taxane chemotherapy (paclitaxel, nab-paclitaxel, or docetaxel) with dual HER2 blockade via trastuzumab and pertuzumab
  • BluePrint® molecular subtyping may reclassify HER2-positive tumors beyond IHC status, potentially identifying distinct subgroups with differential treatment responsiveness
  • Primary endpoints and full eligibility criteria are not yet publicly detailed in available registry data

Why it matters

Pathologic complete response rates in HER2-positive early breast cancer remain variable despite dual anti-HER2 neoadjuvant regimens; genomic subtyping tools like MammaPrint®/BluePrint® may enable more precise patient stratification and regimen tailoring before surgery. Findings from INNOVATE could inform whether molecular reclassification beyond IHC/FISH should be incorporated into routine neoadjuvant planning for this population.

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