Cancer, BreastNCT06409221
VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
An observational study of Cancer, Breast and Triple Negative Breast Cancer, run by Concr at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Breast, Triple Negative Breast Cancer, Early-stage Breast Cancer
- What is being tested?
- Non-interventional study, Observational only
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
Read the 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:
- Arm A: Patients treated with neoadjuvant chemotherapy who had a complete pathological response (n = 100),
- 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:
- Clinical data about the individual, cancer stage at diagnosis, cancer treatment, treatment response and clinical outcome,
- Genomic data from diagnostic breast cancer samples +/- surgical samples,
- Whole Slide Imaging data from tumour sections.
Planned Next Generation Sequencing of tumours:
- RNA sequencing
- DNA sequencing
- 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.
- Being tested
- Non-interventional study, Observational only
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional study, Observational onlyOther
Observational study only, there are no planned interventions.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Retrospective arm recruiting participants (n=100) who have had a complete pathological response to chemotherapy (neoadjuvant) before curative breast surgery. Receives: 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. Receives: Other: Non-interventional study, Observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Identify women with chemotherapy sensitive and chemotherapy resistant breast cancers.
Measured: 24 months
Secondary outcomes (4)
Predict Overall Survival for women diagnosed with early TNBC following neoadjuvant chemotherapy.
Measured: 24 months
Validate algorithm for predicting changes in tumour size in response to neoadjuvant treatment.
Measured: 24 months
Develop a risk of recurrence score for predicting the future probability of developing distant metastases in the early Triple Negative population.
Measured: 24 months
Exploratory biomarker analyses of chemotherapy resistant tumour tissue post neoadjuvant chemotherapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concr
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Marsden NHS Foundation Trust, Institute of Cancer Research, United Kingdom, Durham University
- Responsible party
- Sponsor
- Investigators
- Uzma S Asghar, Study chair, Concr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409221
- Sponsor's protocol ID
- 3.5
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in peer reviewed academic journals as appropriate. Participants will be informed directly of study results.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06409221
- Acronym / sponsor ID
- 3.5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ConcrIndustry (pharma, biotech, devices)
- Collaborators
- Royal Marsden NHS Foundation Trust, Institute of Cancer Research, United Kingdom, Durham University
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Arm A: Patients treated with neoadjuvant chemotherapy who had a complete pathological response (n = 100),
- 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:
- Clinical data about the individual, cancer stage at diagnosis, cancer treatment, treatment response and clinical outcome,
- Genomic data from diagnostic breast cancer samples +/- surgical samples,
- Whole Slide Imaging data from tumour sections.
Planned Next Generation Sequencing of tumours:
- RNA sequencing
- DNA sequencing
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Other: Non-interventional study, Observational onlyRetrospective arm recruiting participants (n=100) who have had a complete pathological response to chemotherapy (neoadjuvant) before curative breast surgery. |
| Arm B | – | Other: Non-interventional study, Observational onlyRetrospective arm recruiting participants (n=100) who had residual cancer burden (non-pathological complete response) in response to chemotherapy (neoadjuvant) followed by curative breast surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Age: ≥ 18 years
- Mental Capacity: Individual should be able to give informed consent, if alive
- Triple Negative Breast Cancer (TNBC)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional study, Observational onlyObservational study only, there are no planned interventions. | Other | Arm A, Arm B |
Primary outcome
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.
Time frame: 24 months
Identify women with chemotherapy sensitive and chemotherapy resistant breast cancers.
Time frame: 24 months
4 secondary outcomes
Predict Overall Survival for women diagnosed with early TNBC following neoadjuvant chemotherapy.
Time frame: 24 months
Validate algorithm for predicting changes in tumour size in response to neoadjuvant treatment.
Time frame: 24 months
Develop a risk of recurrence score for predicting the future probability of developing distant metastases in the early Triple Negative population.
Time frame: 24 months
Exploratory biomarker analyses of chemotherapy resistant tumour tissue post neoadjuvant chemotherapy.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No. Results will be published in peer reviewed academic journals as appropriate. Participants will be informed directly of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uzma S Asghar study chair
Concr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Breast and Triple Negative Breast Cancer, run by Concr at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.