RecruitingPhase 2NCT06441890

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

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


Sponsor

University of Illinois at Chicago

Enrollment

28 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses biomarkers — biological measurements from blood and tumor tissue — to find the best sequence and combination of treatments before surgery (neoadjuvant therapy) for people with HER2-positive breast cancer. HER2-positive means the cancer cells have too many copies of a protein called HER2, which fuels tumor growth. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with HER2-positive invasive breast cancer (confirmed within 90 days) - Your cancer is also confirmed to be the HER2-enriched subtype by a gene expression test - You are in good general health (ECOG performance status 0–2) **You may NOT be eligible if...** - Your breast cancer is not HER2-positive or HER2-enriched subtype - You have already started treatment for this breast cancer - You have had a prior cancer within the last 5 years (except certain early-stage skin cancers) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Illinois

Chicago, Illinois, United States

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NCT06441890


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