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

NCT06409221 | Enrolling By Invitation DMC

• 1 other identifier: 3.5
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Validate accuracy of the Breast cancer therapeutic response predictive algorithm for predicting pathological complete response (pCR) in the early TNBC population treated with neoadjuvant chemotherapy.

  24 months

• Identify women with chemotherapy sensitive and chemotherapy resistant breast cancers.

  24 months

Secondary Outcomes (4)

• Predict Overall Survival for women diagnosed with early TNBC following neoadjuvant chemotherapy.

  24 months

• Validate algorithm for predicting changes in tumour size in response to neoadjuvant treatment.

  24 months

• Develop a risk of recurrence score for predicting the future probability of developing distant metastases in the early Triple Negative population.

  24 months

• Exploratory biomarker analyses of chemotherapy resistant tumour tissue post neoadjuvant chemotherapy.

  24 months

Study Arms (2)

Arm A

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

Other: Non-interventional study, Observational only

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.

Other: Non-interventional study, Observational only

Interventions

Non-interventional study, Observational only OTHER

Observational study only, there are no planned interventions.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with stage 2 or stage 3 Triple Negative Breast cancer on pathological assessment, whom were treated with neoadjuvant chemotherapy followed by curative breast surgery.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Concr: lead
• Royal Marsden NHS Foundation Trust: collaborator
• Institute of Cancer Research, United Kingdom: collaborator
• Durham University: collaborator

Study Sites (1)

Royal Marsden Hospital

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archival tissue samples (FFPE) will be obtained and analytes extracted for analysis, this includes RNA analysis +/- DNA analysis (subject to sample availability).

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Uzma S Asghar

  Concr

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)