Breast CancerPDxBRUTILITYNCT06309615
Decision Impact Study of PreciseDx Breast
An observational study of Breast Cancer, run by Precise Dx, Inc..
Trial summary
The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. Read more about this study
- Who is it for?
- Ages 23 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to 30 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 23 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Accepting all patients newly diagnosed with early stage breast cancer and scheduled for a resection.
Who may be able to join
- Invasive breast cancer (ductal / mixed ductal-lobular)
Who cannot join
- Prior history of invasive breast cancer
- Neoadjuvant therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Clinical Utility / Decision Support Study of an AI-enabled Digital Breast Cancer Test (Precise Dx Breast, PDxBRTM) to Predict Early-stage Breast Cancer Recurrence Within 6 Years
The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC.
Read the detailed description
Female breast cancer (BC) has surpassed lung cancer as the most commonly diagnosed cancer worldwide, which translates into 24.5% of all cancer diagnoses and 15.5% of all cancer death. In the United States, it is estimated that 290,560 Americans will be diagnosed with breast cancer in 2022 and 43,780 will die of disease. Given these statistics, the 2022 National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and College of American Pathologists (CAP) clinical practice guidelines continue to stress the critical importance of the pathology assessment at diagnosis to establish extent of disease and features that reflect a biological potential for recurrence such as histologic grade and stage.
Precise Dx Breast Assay (PDxBR™) is an in vitro prognostic clinically approved test by the NYSDOH to predict breast cancer recurrence for patients diagnosed with early-stage IBC. The test utilizes a digital scan of a representative H\&E-stained resection specimen from the patient. Using advances in applied artificial intelligence (AI) outcome-based image analysis, selected features of the invasive cancer are acquired and combined with clinical variables to produce a risk score predicting likelihood of having breast cancer recurrence within 6-years. With the advent of computational methods, the investigator's investigated whether AI interrogation of whole slide images (WSI) could be used to improve on the characterization and accuracy of IBC histopathology. The approach was based on the generation of quantitative, discreet morphology features within a tissue section (Morphology Feature Array, MFA) and the use of machine learning to create AI models that predict risk of recurrence in early-stage disease. The investigator's developed a test that improves risk stratification of IBC relative to the use of clinical features as well as re-classification of standard breast histologic grade into low- and high-risk groups using MFA-enabled AI models.
- Conditions
- Breast Cancer
- Being tested
- Standard of Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
To use the patients age, tumor size, grade, and lymph node status and any genomic tests (i.e. OncotypeDx, MammaPrint etc to determine risk of recurrence,
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Patients with a diagnosis of early-stage invasive breast cancer, post-surgery, in the process of developing a treatment plan. After a period of 2-4 weeks, patient and provider will receive the PreciseDx breast test results with follow up questionnaires to assess change in care path. Receives: Other: Standard of Care | |
| Standard of Care plus PreciseDx Breast test | Patients with a diagnosis of early-stage invasive breast cancer, post-surgery, in the process of developing a treatment plan. In addition to standard of care the patient and their provider will also receive the results from the PreciseDx breast test. Questionnaires will be utilized to assess impact on decision making and planned care path. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Impact Study of PreciseDx Breast on treating Oncologist
Proportion (target; 20%) of medical oncologists who utilized the PDxBR results in their management of patients with IBC including any of the following decisions / actions: i. overall confirmation or adjustment of original management plan, ii. order / defer genomic testing, iii. adjust type, dose, or regimen of endocrine therapy, iv. introduction of chemotherapy in addition to endocrine treatment, v. use radiotherapy etc.
Measured: 6-12 months
Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist
Proportion (target: 20%) of pathologists who utilized the PDxBR results in their routine diagnostic assessment of IBC including any of the following: i. supported and or changed their diagnostic histologic grade (based on the AI-grade provided by the PDxBR assay), ii. provided additional useful information in the histologic assessment of the IBC including the presence of lymphocytes, stromal content etc. iii. found the interactive smart phone accessible digital feature display tool helpful in their understanding and use of the test results in their assessment process.
Measured: 6-12 months
Secondary outcomes (1)
Decision Impact on long term outcomes
Use of NPV, PPV, Sensitivity, Specificity, HR for predicting local-regional, distant metastasis or overall survival.
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precise Dx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York
- Responsible party
- Sponsor
- Investigators
- Gregory S Henderson, MD, PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309615
- Sponsor's protocol ID
- PDX-001_2
- Acronym
- PDxBRUTILITY
- Status last verified
- May 2025
- First submitted
- 20 Feb 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently there is no plan to make IPD available to other researchers. As this is a multi-site study - depending on patient. numbers - we will collectively evaluate impact on decision making.
Publications
Fernandez G, Zeineh J, Prastawa M, Scott R, Madduri AS, Shtabsky A, Jaffer S, Feliz A, Veremis B, Mejias JC, Charytonowicz E, Gladoun N, Koll G, Cruz K, Malinowski D, Donovan MJ. Analytical Validation of the PreciseDx Digital Prognostic Breast Cancer Test in Early-Stage Breast Cancer. Clin Breast Cancer. 2024 Feb;24(2):93-102.e6. doi: 10.1016/j.clbc.2023.10.008. Epub 2023 Nov 2.
PubMed 38114366Fernandez G, Prastawa M, Madduri AS, Scott R, Marami B, Shpalensky N, Cascetta K, Sawyer M, Chan M, Koll G, Shtabsky A, Feliz A, Hansen T, Veremis B, Cordon-Cardo C, Zeineh J, Donovan MJ. Development and validation of an AI-enabled digital breast cancer assay to predict early-stage breast cancer recurrence within 6 years. Breast Cancer Res. 2022 Dec 20;24(1):93. doi: 10.1186/s13058-022-01592-2.
PubMed 36539895
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Utility / Decision Support Study of an AI-enabled Digital Breast Cancer Test (Precise Dx Breast, PDxBRTM) to Predict Early-stage Breast Cancer Recurrence Within 6 Years
- ClinicalTrials.gov ID
- NCT06309615
- Acronym / sponsor ID
- PDxBRUTILITY / PDX-001_2
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Precise Dx, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 13 Mar 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.
The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC.
Detailed description
Female breast cancer (BC) has surpassed lung cancer as the most commonly diagnosed cancer worldwide, which translates into 24.5% of all cancer diagnoses and 15.5% of all cancer death. In the United States, it is estimated that 290,560 Americans will be diagnosed with breast cancer in 2022 and 43,780 will die of disease. Given these statistics, the 2022 National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and College of American Pathologists (CAP) clinical practice guidelines continue to stress the critical importance of the pathology assessment at diagnosis to establish extent of disease and features that reflect a biological potential for recurrence such as histologic grade and stage.
Precise Dx Breast Assay (PDxBR™) is an in vitro prognostic clinically approved test by the NYSDOH to predict breast cancer recurrence for patients diagnosed with early-stage IBC. The test utilizes a digital scan of a representative H\&E-stained resection specimen from the patient. Using advances in applied artificial intelligence (AI) outcome-based image analysis, selected features of the invasive cancer are acquired and combined with clinical variables to produce a risk score predicting likelihood of having breast cancer recurrence within 6-years. With the advent of computational methods, the investigator's investigated whether AI interrogation of whole slide images (WSI) could be used to improve on the characterization and accuracy of IBC histopathology. The approach was based on the generation of quantitative, discreet morphology features within a tissue section (Morphology Feature Array, MFA) and the use of machine learning to create AI models that predict risk of recurrence in early-stage disease. The investigator's developed a test that improves risk stratification of IBC relative to the use of clinical features as well as re-classification of standard breast histologic grade into low- and high-risk groups using MFA-enabled AI models.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Other: Standard of CarePatients with a diagnosis of early-stage invasive breast cancer, post-surgery, in the process of developing a treatment plan. After a period of 2-4 weeks, patient and provider will receive the PreciseDx breast test results with follow up questionnaires to assess change in care path. |
| Standard of Care plus PreciseDx Breast test | – | Other: Standard of CarePatients with a diagnosis of early-stage invasive breast cancer, post-surgery, in the process of developing a treatment plan. In addition to standard of care the patient and their provider will also receive the results from the PreciseDx breast test. Questionnaires will be utilized to assess impact on decision making and planned care path. |
Who may qualify
- Ages
- 23 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Accepting all patients newly diagnosed with early stage breast cancer and scheduled for a resection.
Key inclusion criteria (1 listed)
- Invasive breast cancer (ductal / mixed ductal-lobular)
Key exclusion criteria (2 listed)
- Prior history of invasive breast cancer
- Neoadjuvant therapy
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 |
|---|---|---|
| Standard of CareTo use the patients age, tumor size, grade, and lymph node status and any genomic tests (i.e. OncotypeDx, MammaPrint etc to determine risk of recurrence, | Other | Standard of Care, Standard of Care plus PreciseDx Breast test |
Primary outcome
Decision Impact Study of PreciseDx Breast on treating Oncologist
Time frame: 6-12 months
Proportion (target; 20%) of medical oncologists who utilized the PDxBR results in their management of patients with IBC including any of the following decisions / actions: i. overall confirmation or adjustment of original management plan, ii. order / defer genomic testing, iii. adjust type, dose, or regimen of endocrine therapy, iv. introduction of chemotherapy in addition to endocrine treatment, v. use radiotherapy etc.
Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist
Time frame: 6-12 months
Proportion (target: 20%) of pathologists who utilized the PDxBR results in their routine diagnostic assessment of IBC including any of the following: i. supported and or changed their diagnostic histologic grade (based on the AI-grade provided by the PDxBR assay), ii. provided additional useful information in the histologic assessment of the IBC including the presence of lymphocytes, stromal content etc. iii. found the interactive smart phone accessible digital feature display tool helpful in their understanding and use of the test results in their assessment process.
1 secondary outcome
Decision Impact on long term outcomes
Time frame: 2-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 38114366Fernandez G, Zeineh J, Prastawa M, Scott R, Madduri AS, Shtabsky A, Jaffer S, Feliz A, Veremis B, Mejias JC, Charytonowicz E, Gladoun N, Koll G, Cruz K, Malinowski D, Donovan MJ. Analytical Validation of the PreciseDx Digital Prognostic Breast Cancer Test in Early-Stage Breast Cancer. Clin Breast Cancer. 2024 Feb;24(2):93-102.e6. doi: 10.1016/j.clbc.2023.10.008. Epub 2023 Nov 2.
- Results publication: PubMed 36539895Fernandez G, Prastawa M, Madduri AS, Scott R, Marami B, Shpalensky N, Cascetta K, Sawyer M, Chan M, Koll G, Shtabsky A, Feliz A, Hansen T, Veremis B, Cordon-Cardo C, Zeineh J, Donovan MJ. Development and validation of an AI-enabled digital breast cancer assay to predict early-stage breast cancer recurrence within 6 years. Breast Cancer Res. 2022 Dec 20;24(1):93. doi: 10.1186/s13058-022-01592-2.
- Individual participant dataSharing planned: Undecided. Currently there is no plan to make IPD available to other researchers. As this is a multi-site study - depending on patient. numbers - we will collectively evaluate impact on decision making.
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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.
Gregory S Henderson, MD, PhD principal investigator
MOUNT SINAI HOSPITAL
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Precise Dx, Inc..
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristian Cruz (6468189330, kcruz@precisedx.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Impact Study of PreciseDx Breast on treating Oncologist (time frame: 6-12 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?
On the ClinicalTrials.gov record for NCT06309615, which also lists 2 linked publications.
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 29 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.