This is a multicenter, blinded prospective study of 2,000 women undergoing mammography
for breast -related symptoms or signs. Breath tests will be performed in order to
demonstrate that the outcome of mammography results combined with breast test results
improves clinical sensitivity and specificity in a group that has an increased prior
probability of cancer. Breath will be collected and analyzed with a rapid point-of-care
instrument (BreathLink™) and also with a laboratory-based assay of samples collected into
an inflatable bag (BreathBag™).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02888366.
Introduction
Clinical perspective on breath testing for breast cancer:
Breast cancer is the most commonly diagnosed cancer in women, in whom it is second only
to lung cancer as a cause of cancer death. The National Cancer Institute estimated that
more than 232,000 US women would be diagnosed with breast cancer in 2013 and nearly
40,000 would die of the disease.
Screening mammography and its limitations: In order to reduce the number of breast cancer
deaths, many countries have established screening mammography programs to detect and
treat early-stage disease. However, the impact of screening mammography on mortality has
been questioned. Also, screening mammography is limited by its very low yield: a 2005
retrospective analysis reported that 510 US radiologists performed 2,289,132 screening
mammograms and found 9,030 cancers i.e. only one cancer was found for every 253
mammograms. 99.6% of all screening mammograms were negative for cancer: they provided
reassurance, but at a human cost of millions of women exposed to potentially hazardous
radiation and discomfort, and a financial cost of several million dollars. Also,
screening mammography may be associated with an increased risk of radiation-induced
breast cancer, as well as with overdiagnosis and overtreatment. Many women decide not to
take the test even when it is readily available, and screening mammography may be
underutilized because of fear of pain and radiation exposure, ethnicity, poverty, and
level of education.
Breath tests - a new diagnostic tool: Abnormal volatile organic compounds (VOCs) in
breath have been identified in breast cancer. Breath VOC biomarkers have been reported in
other disorders including bronchial asthma, lung cancer, active pulmonary tuberculosis,
radiation exposure, and heart transplant rejection. The Food & Drug Administration (FDA)
approved the nitric oxide breath test in bronchial asthma, the urea breath test for H.
pylori, and Menssana Research's Heartsbreath test for heart transplant rejection under
the Humanitarian Device Exemption regulations.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMenssana Research, Inc.
