Identifying Patterns in the Breath of Individuals With Breast Cancer

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

• 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

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

How is the study designed?

Number of groups / cohorts

3

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

Collaborators and Investigators

• Sponsor: Breathe BioMedical Inc
• Collaborators: Mayo Clinic; Duke University; George Washington University; Weinstein Imaging Associates

Study record dates

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: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Machine Learning; Infrared Spectroscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: BBMCP2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No