Triple Negative Breast CancerPEAR-TNBCNCT05435352
Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment
An observational study of Triple Negative Breast Cancer and Triple Negative Breast Neoplasms, run by Ourotech, Inc. at 3 sites in United Kingdom.
Trial summary
Pear Bio has developed an organ-on-a-chip device together with a computer vision pipeline through which the response of an individual patient's tumor to different chemotherapy regimens can be tested simultaneously ex vivo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Triple Negative Breast Neoplasms
- What is being tested?
- Core needle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 6 Jun 2022to 25 Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early TNBC patients due to receive neoadjuvant therapy
Who may be able to join
- Able to give written informed consent prior to admission to this study.
- Female or male aged ≥18 years.
- Histologically confirmed invasive primary breast cancer which is triple-negative by the most recent ASCO/College of American Pathologists (CAP) guidelines.
- Stage I-III breast cancer planned for neoadjuvant chemotherapy followed by surgery.
- Primary breast tumor size ≥10 mm. For patients with bilateral tumors both of the breast tumors have to be TNBC and at least one has to be ≥10 mm.
- Willing to undergo a mandatory additional core needle biopsy from the primary breast mass prior to starting neoadjuvant chemotherapy. Patients with bilateral breast cancer only need to have one tumor biopsied if both tumors are ≥10 mm.
- Willing to donate 40mL of whole blood (cohort B only)
Who cannot join
- Inflammatory breast cancer.
- Inoperable or metastatic TNBC.
- Patients who have already commenced neoadjuvant chemotherapy.
- Treatment concurrently or within 4 weeks of commencing neoadjuvant chemotherapy with any experimental therapies. Patients who are due to receive standard of care neoadjuvant chemotherapy on the control arm of a trial may be eligible after discussion with the medical monitor.
- Secretory or adenoid cystic histological subtypes of triple-negative breast cancer.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Barts Health NHS Trust
London, EC1A 7BE
The Royal Marsden NHS Foundation Trust
London
Manchester University NHS
Manchester
About this study
Official title: Prospective Evaluation of Image-based Artificial Intelligence Research and Development Tool for Precision Neoadjuvant Triple-Negative Breast Cancer Treatment
Pear Bio has developed an organ-on-a-chip device together with a computer vision pipeline through which the response of an individual patient's tumor to different chemotherapy regimens can be tested simultaneously ex vivo. This study will recruit patients with early TNBC who are planned for standard of care neoadjuvant chemotherapy followed by surgery. The oncologist will be blinded to the response on the Pear Bio tool (the assay will be run in parallel with the patient's neoadjuvant chemotherapy). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test against patient outcomes (pathological complete response).
Read the detailed description
This is a multicenter, UK-based, observational pilot study that aims to determine the accuracy of a new assay, the Pear Bio tool, in predicting pathological complete response (pCR) in patients receiving neoadjuvant chemotherapy for early TNBC. Patients will undergo an additional, mandatory biopsy of the breast tumor before commencing neoadjuvant chemotherapy. The biopsy sample will be run on the Pear Bio tool while the patient receives their standard of care neoadjuvant chemotherapy. As such, for this study, the result from the Pear Bio tool will not be used to inform the choice of neoadjuvant chemotherapy and the treating oncologist will be blinded to the assay results. The pathological outcome from surgery (pCR vs non-pCR) will be collected and used to calculate the specificity of the assay as the primary endpoint of the study. Sensitivity, positive predictive value and negative predictive value will also be measured.
- Being tested
- Core needle biopsy
- Keywords
- computer vision, cell culture, microtumor, functional testing, predictive biomarker
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core needle biopsyProcedure or surgery
An additional core needle biopsy is taken to run the Pear Bio test. Test results are not used to inform treatment. Approved neoadjuvant therapy regimens are given to the patient as per standard of care to observe response.
| Study group | Role | What they receive |
|---|---|---|
| Early TNBC patient Cohort A | Early TNBC patients receiving neoadjuvant therapy and providing core needle biopsy.
Any approved neoadjuvant therapy can be used based on physician's choice. Receives: Procedure: Core needle biopsy | |
| Early TNBC patient Cohort B | Early TNBC patients receiving neoadjuvant therapy and providing core needle biopsy and blood.
Any approved neoadjuvant therapy can be used based on physician's choice. Receives: Procedure: Core needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response correlation accuracy (specificity)
The specificity of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Measured: 6 months
Secondary outcomes (3)
Pathological complete response correlation accuracy (sensitivity)
The sensitivity of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Measured: 6 months
Pathological complete response correlation accuracy (positive predictive value)
The positive predictive value of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Measured: 6 months
Pathological complete response correlation accuracy (negative predictive value)
The negative predictive value of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start6 Jun 2022
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies 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
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ourotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435352
- Sponsor's protocol ID
- PEAR-TNBC_ Protocol_v2.0
- Acronym
- PEAR-TNBC
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pseudonymized data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Image-based Artificial Intelligence Research and Development Tool for Precision Neoadjuvant Triple-Negative Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT05435352
- Acronym / sponsor ID
- PEAR-TNBC / PEAR-TNBC_ Protocol_v2.0
- Keywords
- computer vision, cell culture, microtumor, functional testing, predictive biomarker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ourotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 28 Jun 2022 (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.
Pear Bio has developed an organ-on-a-chip device together with a computer vision pipeline through which the response of an individual patient's tumor to different chemotherapy regimens can be tested simultaneously ex vivo. This study will recruit patients with early TNBC who are planned for standard of care neoadjuvant chemotherapy followed by surgery. The oncologist will be blinded to the response on the Pear Bio tool (the assay will be run in parallel with the patient's neoadjuvant chemotherapy). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test against patient outcomes (pathological complete response).
Detailed description
This is a multicenter, UK-based, observational pilot study that aims to determine the accuracy of a new assay, the Pear Bio tool, in predicting pathological complete response (pCR) in patients receiving neoadjuvant chemotherapy for early TNBC. Patients will undergo an additional, mandatory biopsy of the breast tumor before commencing neoadjuvant chemotherapy. The biopsy sample will be run on the Pear Bio tool while the patient receives their standard of care neoadjuvant chemotherapy. As such, for this study, the result from the Pear Bio tool will not be used to inform the choice of neoadjuvant chemotherapy and the treating oncologist will be blinded to the assay results. The pathological outcome from surgery (pCR vs non-pCR) will be collected and used to calculate the specificity of the assay as the primary endpoint of the study. Sensitivity, positive predictive value and negative predictive value will also be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early TNBC patient Cohort A | – | Procedure: Core needle biopsyEarly TNBC patients receiving neoadjuvant therapy and providing core needle biopsy. Any approved neoadjuvant therapy can be used based on physician's choice. |
| Early TNBC patient Cohort B | – | Procedure: Core needle biopsyEarly TNBC patients receiving neoadjuvant therapy and providing core needle biopsy and blood. Any approved neoadjuvant therapy can be used based on physician's choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early TNBC patients due to receive neoadjuvant therapy
Key inclusion criteria (7 listed)
- Able to give written informed consent prior to admission to this study.
- Female or male aged ≥18 years.
- Histologically confirmed invasive primary breast cancer which is triple-negative by the most recent ASCO/College of American Pathologists (CAP) guidelines.
- Stage I-III breast cancer planned for neoadjuvant chemotherapy followed by surgery.
- Primary breast tumor size ≥10 mm. For patients with bilateral tumors both of the breast tumors have to be TNBC and at least one has to be ≥10 mm.
Key exclusion criteria (6 listed)
- Inflammatory breast cancer.
- Inoperable or metastatic TNBC.
- Patients who have already commenced neoadjuvant chemotherapy.
- Treatment concurrently or within 4 weeks of commencing neoadjuvant chemotherapy with any experimental therapies. Patients who are due to receive standard of care neoadjuvant chemotherapy on the control arm of a trial may be eligible after discussion with the medical monitor.
- Secretory or adenoid cystic histological subtypes of triple-negative breast cancer.
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 |
|---|---|---|
| Core needle biopsyAn additional core needle biopsy is taken to run the Pear Bio test. Test results are not used to inform treatment. Approved neoadjuvant therapy regimens are given to the patient as per standard of care to observe response. | Procedure or surgery | Early TNBC patient Cohort A, Early TNBC patient Cohort B |
Primary outcome
Pathological complete response correlation accuracy (specificity)
Time frame: 6 months
The specificity of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
3 secondary outcomes
Pathological complete response correlation accuracy (sensitivity)
Time frame: 6 months
Pathological complete response correlation accuracy (positive predictive value)
Time frame: 6 months
Pathological complete response correlation accuracy (negative predictive value)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. Pseudonymized data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer and Triple Negative Breast Neoplasms, run by Ourotech, Inc. at 3 sites 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: Lack of funding). 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?
Pathological complete response correlation accuracy (specificity) (time frame: 6 months). 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 30 Jul 2025.