Breathe BioMedical Expands Multi-Center Breast Cancer Breath Test Trial

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-17

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Breathe BioMedical announced the launch of the second site in its multi-center observational study evaluating a breath test for early breast cancer detection in women with dense breasts. The study, co-led by researchers from Mayo Clinic and Duke University, will compare breath profiles of women with and without breast cancer to identify disease-specific patterns. The company's technology analyzes breath samples for biomarkers using a proprietary spectrometer and machine learning algorithms. This expansion aims to diversify the study population and improve the robustness of the algorithms, ultimately enhancing early breast cancer detection.

Key Highlights

  • Launch of second site (Duke University) in a multi-center clinical trial for a breath test to detect breast cancer.
  • Study focuses on women with dense breasts, a high-risk group for breast cancer.
  • Breath samples are analyzed using proprietary spectrometer and machine learning algorithms.
  • Trial aims to improve early detection of breast cancer as an adjunct to mammography.

Incidence and Prevalence

Global Breast Cancer Burden (2022):

  • New Cases: 2.3 million
  • Deaths: 670,000

Projected Burden (2050):

  • Increase in New Cases: 38%

  • Increase in Deaths: 68%

  • This increase will disproportionately affect low-HDI (Human Development Index) countries.

Trends:

  • Incidence Rates: Increased by 1-5% annually in half of the countries examined.
  • Mortality Rates: Decreased in 29 very high-HDI countries. Seven countries (e.g., Belgium and Denmark) are meeting the WHO Global Breast Cancer Initiative's goal of at least a 2.5% annual decrease.

Additional Information:

  • Breast cancer is the most diagnosed cancer in women globally.
  • Lung cancer is the leading cause of cancer death in both men and women.
  • There are significant disparities in breast cancer incidence and mortality based on race/ethnicity and socioeconomic factors.
  • Improvements in early diagnosis and access to treatment are crucial for reducing the global burden of breast cancer, especially in low- and medium-HDI countries.

Note: Prevalence data was not explicitly provided in the given sources, which primarily focused on incidence and mortality.

Unmet Needs and Targeted Populations in Breast Cancer Research (Based on PubMed Publications from 2020-2023)

Breast cancer research continues to evolve, driven by the need to address persistent challenges and improve outcomes for all patients. Based on PubMed publications from the past three years, several key unmet needs and targeted populations emerge:

1. Brain Metastases in HER2-Positive Breast Cancer:

  • Historically, patients with brain metastases have been excluded from clinical trials, leading to a lack of data on optimal treatment strategies. Research highlights the need for standardized clinical trial designs that include these patients to ensure access to effective therapies. Specifically, the heterogeneity in eligibility criteria, CNS-focused endpoints, and statistical analysis across trials makes it difficult to interpret the global treatment landscape and identify best practices.

2. Advanced Breast Cancer and Supportive Care Needs:

  • Studies consistently demonstrate a high prevalence of unmet supportive care needs among individuals with advanced breast cancer. These needs span various domains, including psychological/emotional, health system/information, interpersonal/intimacy, social, physical, family, practical, daily living, spiritual, patient-clinician communication, and cognitive needs. Addressing these needs is crucial for improving quality of life and overall well-being.

  • Specific needs: Fear of recurrence, distress, depression, anxiety, financial concerns, and access to information are frequently cited. Younger women with advanced breast cancer often report poorer quality of life and more unmet needs compared to older women.

3. Triple-Negative Breast Cancer (TNBC):

  • TNBC remains a significant challenge due to its aggressive nature, high relapse rates, and limited treatment options beyond chemotherapy. Research focuses on identifying new drug targets and therapeutic strategies to improve outcomes. Key areas of investigation include targeting specific molecular signaling pathways, genetic mutations, and exploring the role of the tumor microenvironment.

  • Unmet needs: Effective targeted therapies, overcoming chemo-resistance, and addressing disparities in access to care are crucial.

4. Young Women with Breast Cancer:

  • Younger breast cancer survivors (<50 years) face unique challenges related to their age and life stage, including fertility concerns, early menopause, and navigating work and family responsibilities. Studies highlight the need for age-specific information and support services to address these concerns. Informational needs, particularly regarding treatment-related physical and emotional changes, fertility, menopause, relationships, work challenges, and transitioning into survivorship, are often unmet.

  • Specific needs: Addressing fear of recurrence, anxiety, and providing tailored information are essential for improving quality of life in this population.

5. Underserved Populations:

  • Disparities in access to quality breast cancer care exist across various populations, including migrants, individuals of lower socioeconomic status, and those in resource-limited settings. Research emphasizes the need for targeted interventions and policies to reduce these disparities and ensure equitable access to screening, diagnosis, treatment, and supportive care services.

  • Specific needs: Addressing language barriers, cultural sensitivities, financial constraints, and geographic limitations are crucial for improving outcomes in underserved communities.

6. Male Breast Cancer:

  • Although rare, male breast cancer presents unique challenges due to the lack of male-specific information and support services. Research highlights the need for tailored resources to address the specific needs of men diagnosed with breast cancer, including information on symptoms, diagnosis, treatment options, side effects, and psychosocial support.

7. Long-Term Survivors:

  • Even years after treatment, breast cancer survivors may experience persistent physical and psychosocial challenges, including fear of recurrence, fatigue, pain, and financial difficulties. Research emphasizes the importance of ongoing survivorship care to address these long-term needs and ensure optimal well-being.

8. Improving Clinical Trial Design:

  • Several studies highlight the need for standardization of clinical trial design for breast cancer, particularly for populations traditionally excluded or underrepresented, such as those with brain metastases, older adults, and individuals from diverse backgrounds. This includes standardizing eligibility criteria, CNS-focused endpoints, and statistical analysis to facilitate interpretation of results and ensure that trial findings are applicable to a broader range of patients.

9. Optimizing Patient-Provider Communication:

  • Effective communication between patients and healthcare providers is essential for shared decision-making and addressing unmet informational needs. Research suggests that many breast cancer patients desire more information from their providers, particularly regarding treatment options, side effects, and long-term implications of the disease. Improving communication skills among healthcare professionals and providing patients with clear, accessible information are crucial for enhancing patient experience and satisfaction.

Addressing these unmet needs and tailoring interventions to specific populations are crucial for improving outcomes and ensuring equitable access to quality breast cancer care for all.

Drug used in other indications

Breath tests are being investigated for various cancer types beyond breast cancer, offering a potentially non-invasive diagnostic approach. Here's a summary of some of the cancers and the intervention models used in the trials:

  • Lung Cancer: A study investigated breath analysis for early lung cancer detection using a BIO-VOC sampler and Thermal Desorption-Gas Chromatography-Mass Spectrometry (TD-GC/MS). They identified 13 VOCs with significant differences between lung cancer patients and controls. A combination of eight VOCs showed an AUC of 0.85, 82% sensitivity, and 76% specificity in the initial set, and an AUC of 0.78, 78% sensitivity, and 64% specificity in an independent cohort.

  • Colorectal Cancer: Multiple studies have explored VOCs in breath as potential biomarkers for colorectal cancer. These studies often involve gas chromatography-mass spectrometry or sensor array technologies to analyze breath samples and distinguish cancer patients from healthy controls.

  • Esophagogastric Cancer (OGC): A multicenter validation study evaluated a breath test for OGC diagnosis using selected ion flow tube mass spectrometry (SIFT-MS). Breath samples were collected in steel breath bags and analyzed with SIFT-MS. A 5-VOCs model achieved 80% sensitivity, 81% specificity, and an AUC of 0.85.

  • Gastric Cancer: Breath analysis has been studied for gastric cancer detection, primarily using mass spectrometry (MS)-based methods. Studies have shown sensitivities ranging from 67% to 100% and specificities from 71% to 98%. MS-based breath tests demonstrated a summary sensitivity of 82.4% and specificity of 91.3%.

  • Head and Neck Squamous Cell Carcinoma (HNSCC): A study assessed breath analysis for HNSCC detection using a selected ion flow-tube mass spectrometer. A logistic regression model based on three variables achieved 80% sensitivity, 86% specificity, and an AUC of 0.821.

  • General Cancer Detection: A systematic review and meta-analysis evaluated VOC breath tests for various cancers, finding 87% sensitivity, 81% specificity, and an AUC of 0.93. Another review covering studies up to 2017 reported a pooled AUC of 0.94, 79% sensitivity, and 89% specificity.

It's important to note that while these results are promising, further research and standardization are needed before breath tests become widely adopted in clinical practice.