VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study

Triple Negative Breast Cancer Clinical Trial

Official title: VISION: Defining Biomarkers of Chemotherapy & Immunotherapy Response and Validation of the Breast Cancer Therapeutic Response Predictive Algorithm for Early Triple Negative Breast Cancers

Status Enrolling by invitation

Clinical Trial Summary

Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis. There is an urgent need to identify reliable biomarkers of response for chemotherapy and immunotherapy.

Study Aims: To update Concr's existing predictive algorithms specifically for use in women newly diagnosed with TNBC.

The plan is develop technology which will predict which drug the cancer will respond best to, treatment A vs. treatment B AND how the individual's prognosis could change if treatment A is chosen overtreatment B.

Study Design: The VISION study is a clinical study looking back in time (retrospective study), specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery. The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concr's existing treatment prediction algorithms. Hence there are no extra research biopsies needed in order to participate in the Study.

Study Sites: UK and Australia

Study Funding: This study is funded by the a Techbio company called Concr with support from Innovate UK (UK Government funding).

Clinical Trial Description

VISION is a commercially sponsored clinical trial designed to be a retrospective, observational non-CTIMP research study which will collect archival tumour samples from participants previously treated with chemotherapy +/- immunotherapy for early Triple Negative Breast Cancer (TNBC).

Current Study design:

VISION currently has 2 retrospective patient cohorts:

1. Arm A: Patients treated with neoadjuvant chemotherapy who had a complete pathological response (n = 100),

2. Arm B: Patients treated with neoadjuvant chemotherapy who had a residual cancer burden (n=100).

Planned study design: Include a prospective arm, Arm C to test feasibility of generating treatment predictions in real time.

Study sites: UK and Australia

Study timelines: 2 years UK start date: April 26th, 2024

Datasets planned for collection are:

1. Clinical data about the individual, cancer stage at diagnosis, cancer treatment, treatment response and clinical outcome,

2. Genomic data from diagnostic breast cancer samples +/- surgical samples,

3. Whole Slide Imaging data from tumour sections.

Planned Next Generation Sequencing of tumours:

1. RNA sequencing

2. DNA sequencing

3. Other NGS approaches or -OMICS (subject to tissue availability)

Planned tissue collection:

Tissue type: Archival FFPE samples Diagnostic samples (before chemotherapy) +/- surgical samples (after chemotherapy)

Planned technology development:

Existing Concr technology which predicts cancer response, currently pan-cancer, in the early Triple Negative Breast Cancer population A key objective is to demonstrate that accurate prediction of therapeutic response for chemotherapy, specifically anthracyclines, taxanes, platinums, anti-metabolites with/without immunotherapy. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Early-stage Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT06409221
• Study type: Observational
• Source: Concr
• Status: Enrolling by invitation
• Start date: May 1, 2024
• Completion date: December 31, 2025