Recruiting

Breath Analysis

Sponsor:

Breathe BioMedical Inc

Code:

NCT06512350

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

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.

Conditions

Breast Cancer

Study ID

NCT06512350

Start date

Feb 25, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

5175 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • Primary Outcome 1 [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Sandra Veenstra

(506) 855-2400sandra.veenstra@breathebiomedical.com

Locations

GW Comprehensive Breast Center

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Geoffrey Rutledge, MD

grutledge@mfa.gwu.edu

Principal Investigator:

Geoffrey Rutledge, MD

Mayo Clinic Breast Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

James Jakub, MD

Duke University Medical Cente

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jennifer Plichta, MD

919-684-6849jennifer.plichta@duke.edu

Principal Investigator:

Jennifer Plichta, MD

More Information

Sponsor

Breathe BioMedical Inc

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Breast Cancer
  • Infrared Spectroscopy
  • Machine Learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Breathe BioMedical Inc on 2026-04-22.