Breast CancerNCT06512350
Identifying Patterns in the Breath of Individuals With Breast Cancer
An observational study of Breast Cancer, run by Breathe BioMedical Inc at 5 sites in 2 countries.
Trial summary
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 5,175 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 25 Feb 2025to Feb 2028
- 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 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population will be women aged 40-74. Women who are scheduled for standard of care breast biopsy or MRI will be recruited, and breath will be collected prior to breast biopsy or MRI. Those with biopsy-proven primary breast cancer will be assigned to the case cohort (true positives). Subjects in this cohort who are proceeding to breast surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample, 6 months after the completion of treatment. To be eligible for the control cohort, subjects must have a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer (true negatives). Individuals who have received an MRI up to 8 weeks prior to breath sample collection may be approached, granted inclusion and exclusion criteria are met. Subjects will be recruited from participating clinical centers in Canada and the United States.
Who may be able to join
- Female (sex as assigned at birth);
- Aged 40 - 74 years;
- Mammography confirmed breast tissue density (BI-RADS density score of A, B, C or D);
- Scheduled for standard of care biopsy or MRI;
- Fluent in language of consent (English, Spanish, or French);
- Ability to give informed consent;
- Able to provide a breath sample.
Who cannot join
- Prior history of breast cancer;
- Previous surgical biopsy or surgical excision of breast cancer in the past six months;
- History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
- Acute respiratory infection and/or symptoms in the past seven days;
- MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
- Pregnant or become pregnant during the study.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Duke University Medical Cente
Durham, North Carolina, 27710
Jennifer Plichta, MD, 919-684-6849, jennifer.plichta@duke.edu
Jennifer Plichta, MD
- Recruiting
Mayo Clinic Breast Clinic
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015
James Jakub, MD
- Not yet recruiting
Weinstein Imaging Associates
Pittsburgh, Pennsylvania, 15220
Danielle E Sharek, MD, 412-440-6999
Danielle E Sharek, MD
- Recruiting
GW Comprehensive Breast Center
Washington D.C., District of Columbia, 20037
Geoffrey Rutledge, MD, grutledge@mfa.gwu.edu
Geoffrey Rutledge, MD
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, E1C 2Z3
Jocelyne Hébert, MD, 506-862-7966
Jocelyne Hébert, MD
About this study
Official title: Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.
Women with mammogram-confirmed breast tissue density undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results.
Read more
The primary goal of this project is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's cavity ring-down spectrometer to further develop Breathe BioMedical's technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women aged 40 to 74.
Secondarily, this project aims to identify patterns of VOCs that are either over- or under-represented in participants with breast cancer when compared to the breath profiles of participants without breast cancer. This project will also assess performance characteristics of the technology (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This project aims to understand intra-subject variability by exploring differences in breath signatures before and after definitive management of breast cancer, including surgical resection.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Infrared Spectroscopy, Machine Learning
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Cohort | Subjects with biopsy-proven primary breast cancer. | |
| Control Cohort | Subjects with a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer. | |
| Breast Cancer Cohort - Surgery | Subjects with biopsy-proven primary breast cancer, who have undergone surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample. The second breath sample will be collected at least six months following the completion of all standard of care treatment (excluding adjuvant endocrine therapy and adjuvant HER2 directed monoclonal antibody such as trastuzumab). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1
Classification performance metrics characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) derived from spectral features of exhaled alveolar breath obtained using Breathe BioMedical's cavity ring-down spectrometer in women aged 40-74.
Measured: 36 months
Secondary outcomes (5)
Secondary Outcome 1
Discriminative features between women with breast cancer and women without breast cancer.
Measured: 36 months
Secondary Outcome 2
Features associated with breast cancer between participants with dense breast tissue and those with non-dense breast tissue.
Measured: 36 months
Secondary Outcome 3
Classification performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.
Measured: 36 months
Secondary Outcome 4
Variability in features before and after definitive management of breast cancer, including surgical resection.
Measured: 36 months
Secondary Outcome 5
Pooled and analyzed de-identified data from this, previous, and future breath analysis studies to continue to develop Breathe BioMedical's technology and machine learning algorithms.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start25 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 5,175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Breathe BioMedical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, George Washington University, Duke University, Weinstein Imaging Associates, Réseau de Santé Vitalité Health Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512350
- Sponsor's protocol ID
- BBMCP2024
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer
- ClinicalTrials.gov ID
- NCT06512350
- Acronym / sponsor ID
- BBMCP2024
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Infrared Spectroscopy, Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,175 participants (estimated)
- Lead sponsor
- Breathe BioMedical IncIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, George Washington University, Duke University, Weinstein Imaging Associates, Réseau de Santé Vitalité Health Network
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Jul 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.
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.
Women with mammogram-confirmed breast tissue density undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results.
The primary goal of this project is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's cavity ring-down spectrometer to further develop Breathe BioMedical's technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women aged 40 to 74.
Secondarily, this project aims to identify patterns of VOCs that are either over- or under-represented in participants with breast cancer when compared to the breath profiles of participants without breast cancer. This project will also assess performance characteristics of the technology (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This project aims to understand intra-subject variability by exploring differences in breath signatures before and after definitive management of breast cancer, including surgical resection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Cohort | – | –Subjects with biopsy-proven primary breast cancer. |
| Control Cohort | – | –Subjects with a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer. |
| Breast Cancer Cohort - Surgery | – | –Subjects with biopsy-proven primary breast cancer, who have undergone surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample. The second breath sample will be collected at least six months following the completion of all standard of care treatment (excluding adjuvant endocrine therapy and adjuvant HER2 directed monoclonal antibody such as trastuzumab). |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be women aged 40-74. Women who are scheduled for standard of care breast biopsy or MRI will be recruited, and breath will be collected prior to breast biopsy or MRI. Those with biopsy-proven primary breast cancer will be assigned to the case cohort (true positives). Subjects in this cohort who are proceeding to breast surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample, 6 months after the completion of treatment. To be eligible for the control cohort, subjects must have a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer (true negatives). Individuals who have received an MRI up to 8 weeks prior to breath sample collection may be approached, granted inclusion and exclusion criteria are met. Subjects will be recruited from participating clinical centers in Canada and the United States.
Key inclusion criteria (7 listed)
- Female (sex as assigned at birth);
- Aged 40 - 74 years;
- Mammography confirmed breast tissue density (BI-RADS density score of A, B, C or D);
- Scheduled for standard of care biopsy or MRI;
- Fluent in language of consent (English, Spanish, or French);
Key exclusion criteria (6 listed)
- Prior history of breast cancer;
- Previous surgical biopsy or surgical excision of breast cancer in the past six months;
- History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
- Acute respiratory infection and/or symptoms in the past seven days;
- MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome 1
Time frame: 36 months
Classification performance metrics characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) derived from spectral features of exhaled alveolar breath obtained using Breathe BioMedical's cavity ring-down spectrometer in women aged 40-74.
5 secondary outcomes
Secondary Outcome 1
Time frame: 36 months
Secondary Outcome 2
Time frame: 36 months
Secondary Outcome 3
Time frame: 36 months
Secondary Outcome 4
Time frame: 36 months
Secondary Outcome 5
Time frame: 36 months
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 18 Sep 2026.
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Breathe BioMedical Inc at 5 sites in 2 countries.
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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
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 Sandra Veenstra ((506) 855-2400 ext. 234, sandra.veenstra@breathebiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1 (time frame: 36 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 18 Sep 2026.