Identifying Patterns in the Breath of Individuals With Breast Cancer

April 16, 2026 updated by: Breathe BioMedical Inc

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.

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 Overview

Status

Recruiting

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Estimated)

5175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sandra Veenstra
Phone Number: 234 (506) 855-2400
Email: sandra.veenstra@breathebiomedical.com

Study Locations

United States
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Recruiting
    - GW Comprehensive Breast Center
    - Contact:
      
      Geoffrey Rutledge, MD
      
      Email: grutledge@mfa.gwu.edu
    - Principal Investigator:
      
      Geoffrey Rutledge, MD
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Breast Clinic
    - Contact:
      
      Clinical Trials Referral Office
      
      Phone Number: 855-776-0015
    - Principal Investigator:
      
      James Jakub, MD
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Cente
    - Principal Investigator:
      
      Jennifer Plichta, MD
    - Contact:
      
      Jennifer Plichta, MD
      
      Phone Number: 919-684-6849
      
      Email: jennifer.plichta@duke.edu
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15220
    - Not yet recruiting
    - Weinstein Imaging Associates
    - Contact:
      
      Danielle E Sharek, MD
      
      Phone Number: 412-440-6999
    - Principal Investigator:
      
      Danielle E Sharek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome 1 Time Frame: 24 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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome 1 Time Frame: 24 months	Discriminative features between women with breast cancer and women without breast cancer.	24 months
Secondary Outcome 2 Time Frame: 24 months	Features associated with breast cancer between participants with dense breast tissue and those with non-dense breast tissue.	24 months
Secondary Outcome 3 Time Frame: 24 months	Classification performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.	24 months
Secondary Outcome 4 Time Frame: 24 months	Variability in features before and after definitive management of breast cancer, including surgical resection.	24 months
Secondary Outcome 5 Time Frame: 24 months	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.	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Breathe BioMedical Inc

Collaborators

Mayo Clinic

Duke University

George Washington University

Weinstein Imaging Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria