Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer — BiOnHER  

Breast Cancer Clinical Trial

Official title: Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer (BiOnHER)

Status Recruiting

Clinical Trial Summary

Non-randomized, open label, translational research study in women with early HER2-positive invasive breast carcinoma eligible for neoadjuvant treatment.

The aim of BIONHER is to assess the impact of short-term neoadjuvant dual HER2-blockade on HER2-positive breast cancer transcriptomic profile and to evaluate whether early on treatment tumor biopsy can improve the accuracy of predicting response over the pre-treatment alone.

Clinical Trial Description

This is a prospective study of paired tumor samples from patients with newly diagnosed HER2-positive breast cancer eligible for neoadjuvant treatment to evaluate whether early on-treatment biomarkers can improve the accuracy of predicting response over pre-treatment samples alone.

Sequential tumor biopsies will be obtained at two time points: before initiation of neoadjuvant dual HER2-blockade (pre-treatment, day 1) and 1 week later (day 8), before introduction of paclitaxel to the neoadjuvant treatment.

Following the completion of neoadjuvant paclitaxel, trastuzumab and pertuzumab (THP) for 16 weeks, patients will proceed to surgery. After surgery, adjuvant treatment (including need for Anthracyclines) will be followed as per clinical practice.

The study will comprise two phases: a discovery phase (n=60) where sequential paired tumor biopsies will be used for RNA-Seq analysis and assessment of tumor infiltrating lymphocytes (TILs) and CelTIL score. Radiomic characteristics of MRI, HER2Dx® and spatial transcriptomics (using GeoMx®) will be also evaluated.

This phase will be followed by a validation phase (n=20) in which prediction accuracy observed in the discovery phase will be validated by Nanostring gene expression analysis using a new cohort of patients with HER2-positive breast cancer eligible for neoadjuvant therapy. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Neoplasms

• NCT number: NCT05912062
• Study type: Observational
• Source: Institut Català d'Oncologia
• Contact: Sonia Pernas, MD PhD
• Phone: +34932607744
• Email: contactfortrials_lh@iconcologia.net
• Status: Recruiting
• Start date: March 22, 2021
• Completion date: December 1, 2024