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

NCT ID: NCT06409221

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-12-31

Brief 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).

Detailed 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.

Conditions

Cancer, Breast; Triple Negative Breast Cancer; Early-stage Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Arm A

Retrospective arm recruiting participants (n=100) who have had a complete pathological response to chemotherapy (neoadjuvant) before curative breast surgery.

Non-interventional study, Observational only

Intervention Type: OTHER

Observational study only, there are no planned interventions.

Arm B

Retrospective arm recruiting participants (n=100) who had residual cancer burden (non-pathological complete response) in response to chemotherapy (neoadjuvant) followed by curative breast surgery.

Non-interventional study, Observational only

Intervention Type: OTHER

Observational study only, there are no planned interventions.

Interventions

Non-interventional study, Observational only

Observational study only, there are no planned interventions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: ≥ 18 years
• Mental Capacity: Individual should be able to give informed consent, if alive
• Triple Negative Breast Cancer (TNBC)

• Oestrogen receptor (ER) negative with an Allred score of ≤ 2 or, equivalent pathology scoring system e.g., ≤10% (0 - 10%) tumour nuclei staining
• HER2 negative: 1+ on immunohistochemistry or 2+ immunohistochemistry and FISH/D-Dish negative
• Progesterone receptor (PgR) negative = PgR score of ≤2 or equivalent pathology scoring system e.g., ≤10% (0 - 10%) tumour nuclei staining
• Androgen receptor (AR) status (if known): negative or positive
• TNBC phenotype: HER2 negative tumours with borderline ER or PgR scoring on immunohistochemistry e.g., ER 3/8 and PgR 0/3 negative which were managed as early TNBC can be included but should be discussed on a case-by-case basis prior to study registration with Principal Investigator.
• Lymph node involvement: Lymph node negative or positive; any number including clinical/pathological N3 involvement (TNM staging ≥ V.8.0)
• Cancer Staging: Stage 2 or stage 3 breast cancer
• Treated considered standard of care neoadjuvant chemotherapy: an anthracycline, a taxane, an alkylating agent, +/- a platinum, +/- immunotherapy
• Available archival tissue samples

Exclusion Criteria

• Stage IV de novo metastatic breast cancer are not eligible
• Stage I breast cancers are not eligible
• Women who were diagnosed with more than one cancer type within 3 years of the breast cancer diagnosis of TNBC are not eligible
• Received neoadjuvant radiotherapy
• Received neoadjuvant endocrine treatment
• Women pregnant at the time of the TNBC diagnosis
• Significant medical co-morbidities which could have influenced the participant's prognosis are excluded. Examples include cardiac failure, moderate - severe renal failure, active hepatitis, HIV, active TB, ischaemic heart disease etc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: collaborator

Durham University

OTHER

Sponsor Role: collaborator

Concr

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uzma S Asghar

Role: STUDY_CHAIR

Concr

Locations

Royal Marsden Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

3.5

Identifier Type: -

Identifier Source: org_study_id