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Blowing away breast cancer: a breath test could spot the disease early

NCT ID NCT06512350

Diagnosis Sponsor: Breathe BioMedical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study is testing whether a breath test can detect breast cancer in women aged 40 to 74. Researchers will collect breath samples from over 5,000 women before their standard biopsy or MRI and compare the chemical patterns between those found to have cancer and those who do not. The goal is to develop a non-invasive, easy screening tool that could help catch breast cancer earlier.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,175 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

40 to 74 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont

    RECRUITING

    Moncton, New Brunswick, E1C 2Z3, Canada

  • Duke University Medical Cente

    RECRUITING

    Durham, North Carolina, 27710, United States

  • GW Comprehensive Breast Center

    RECRUITING

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

  • Mayo Clinic Breast Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Weinstein Imaging Associates

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15220, United States

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