Identifying Patterns in the Breath of Individuals With Breast Cancer

NCT06512350 | Recruiting

• 1 other identifier: BBMCP2024
• Study Type: observational
• Target: 5,175
• Locations: 1 country
• Sites: 4

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

Keywords

Breast Cancer; Infrared Spectroscopy; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Secondary Outcome 1

  24 months

• Secondary Outcome 2

  24 months

• Secondary Outcome 3

  24 months

• Secondary Outcome 4

  24 months

• Secondary Outcome 5

  24 months

Study Arms (3)

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).

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Breathe BioMedical Inc: lead
• Mayo Clinic: collaborator
• George Washington University: collaborator
• Duke University: collaborator
• Weinstein Imaging Associates: collaborator

Study Sites (4)

GW Comprehensive Breast Center

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

RECRUITING

Mayo Clinic Breast Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Duke University Medical Cente

Durham, North Carolina, 27710, United States

RECRUITING

Weinstein Imaging Associates

Pittsburgh, Pennsylvania, 15220, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sandra Veenstra

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (4)