Identifying Patterns in the Breath of Individuals With Breast Cancer

This study is looking for unique patterns in the breath of women with breast cancer to help find new ways to detect the disease. Researchers will compare breath samples from women who have breast cancer with those who do not. You may be able to join if you are a woman between 40 and 74 years old, have dense breast tissue confirmed by a mammogram, and are scheduled for a biopsy or MRI. The study aims to see if these breath patterns can help with earlier breast cancer detection, with results being looked at over 24 months. The current recruitment status is unclear.

Study design: This is an observational study planning to enroll 5175 women. It compares breath profiles between women with and without breast cancer.
What's involved: You would provide one breath sample and fill out a questionnaire about your medical history with help from research staff. This happens before your scheduled biopsy or MRI.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome will be measured at 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Identifying Patterns in the Breath of Individuals With Breast Cancer

Recruiting

Not specifiedAges 40–74Observational

Breathe BioMedical Inc

~5,175 participants

Updated 2026-04-22 on ClinicalTrials.gov

At a glance

Recruiting sites

3 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Primary Outcome 1

Measured over 24 months

Conditions

Breast Cancer

Where it's being run

4 sites across 4 states

District of Columbia1

Florida1

North Carolina1

Pennsylvania1

Who to contact

Sandra Veenstra

[email protected]

(506) 855-2400 · ext. 234

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Primary Outcome 124 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.

Trialytics