Identifying Patterns in the Breath of Individuals With Breast Cancer

Breathe BioMedical Inc

Status: Enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06512350

BBMCP2024

Details and patient eligibility

About

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 dense breast tissues 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 with dense breast tissue.

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female (sex as assigned at birth);
• Aged 40 - 74 years;
• Mammography confirmed dense breast tissue (BI-RADS density score of 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

• Mammography confirmed fatty breast tissue (BI-RADS A or B);
• 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 design

1,000 participants in 3 patient groups

Breast Cancer Cohort

Description:

Subjects with mammography-confirmed dense breast tissue (BI-RADS density score of C or D) and with biopsy-proven primary breast cancer.

Control Cohort

Description:

Subjects with mammography-confirmed dense breast tissue (BI-RADS density score of C or D) and 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

Description:

Subjects with mammography-confirmed dense breast tissue (BI-RADS density score of C or D) and with biopsy-proven primary breast cancer, who have undergone surgery at Mayo Clinic Florida 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).