NCT05912062

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HER2-positive Breast Cancer
• Neoplasms
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab (neoadjuvant)	Trastuzumab loading dose at 8mg/kg at day 1 followed by Trastuzumab at 6mg/kg in a 21-day cycle for six cycles
DRUG	Pertuzumab (neoadjuvant)	Pertuzumab loading dose at 840mg at day 1 followed by Pertuzumab at 420mg in a 21-day cycle for six cycles
DRUG	Paclitaxel (neoadjuvant)	Paclitaxel starting at day 8 at 80mg/m2, days 1, 8, and 15 of a 21-day cycle for up to fifteen weeks

Timeline

• Start date: 2021-03-22
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-06-22
• Last updated: 2023-09-29

Locations

1 site across 1 country: Spain