Loading clinical trials...

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06441890•University of Illinois at Chicago

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 Oncologist recommends neoadjuvant chemotherapy
•No evidence of distant metastatic disease
•AJCC clinical stage: cT1c-T3, cN0-N2
•Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration.
+7 more criteria

Exclusion Criteria

•Any prior therapy for this breast cancer
•Active infection requiring systemic therapy at the time of study registration
•Pregnant or nursing
•Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
•Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
•Other major comorbidity (e.g., compromised liver function, major cardiovascular or cerebrovascular event within the past 6 months, uncontrolled diabetes mellitus or hypertension), as determined by treating physician.
•Any contraindication for any chemotherapy drug used in the assigned regimen.
•Baseline sensory neuropathy \> grade 1
•History of hypersensitivity to any of the drugs in the treatment regimen. Patients with history of hypersensitivity may be treated on this protocol with either nab-paclitaxel or docetaxel.
•Prisoners

Locations (1)

University of Illinois

Chicago, Illinois, United States

Key Dates

Start Date

December 5, 2024

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

July 14, 2025

Enrollment

ESTIMATED participants

Conditions

Breast CancerHER2-positive Breast Cancer

Interventions

Paclitaxel

DRUG

Nab-paclitaxel

DRUG

Docetaxel

DRUG

Trastuzumab

DRUG

Pertuzumab

DRUG

Contacts

kent hoskins

CONTACT

3123550496 khoski@uic.ed

Mercedes Carrasquillo, BS

CONTACT

3124131902 micarras@uic.edu

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer