Bexa Breast Exam for Breast Cancer Detection

(BBE Trial)

Overseen By Johanna Garzon, MHA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sure, Inc.

Disqualifiers: Breast cancer history, Mastectomy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Bexa Breast Exam treatment for breast cancer detection?

Research on breast self-examination (BSE), a similar method, shows that it can help detect breast cancer earlier by identifying smaller tumors and improving survival rates, especially in post-menopausal women. While BSE is not as sensitive as mammograms, it is a useful additional tool for early detection. ^{1 2 3 4 5}

How is the Bexa Breast Exam treatment different from other breast cancer detection methods?

The Bexa Breast Exam is unique because it focuses on a specific examination technique for early breast cancer detection, unlike mammography which may not be accessible to all women. It emphasizes self-examination, which is a self-care method that women can perform regularly to detect changes in their breasts. ^{3 5 6 7 8}

What is the purpose of this trial?

Objective: The "Bexa Breast Exam," or "BBE," for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable, focused ultrasound examination to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Breast ExamTM," and abbreviated as, "BBE." This study compares the Bexa Breast Exam (BBE) to the standard of care (digital breast tomosynthesis) in detecting masses and as a breast cancer early detection examination. The specific objectives are: 1. To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis in the general population of women over 30 without a history of breast cancer. 2. To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis identifying breast masses including cancer in women with dense breasts. 3. To demonstrate the proportion of women receiving a BBE that require additional imaging studies. Hypothesis: The purpose of this study is to demonstrate that the Bexa Breast Examination's sensitivity and specificity in identifying abnormal breast masses is comparable to the current accepted standard of care, mammography with tomosynthesis.

Research Team

John Cole, DO

Principal Investigator

Hendrick Health

Eligibility Criteria

This trial is for women over 30 without a history of breast cancer. It's specifically looking at those with dense breasts to see if the Bexa Breast Exam (BBE) can find abnormal masses as well as standard mammography with tomosynthesis does.

Inclusion Criteria

Women of all races, ethnicities, and socio-economic backgrounds

I am a woman aged between 30 and 75.

I am a woman going for a screening mammogram.

Exclusion Criteria

Palpable lesion (to the participant)

Greater than 3 positive findings in a given breast

Women who are unable to comprehend or unwilling to sign an informed consent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the Bexa Breast Exam and digital breast tomosynthesis for mass detection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

8 weeks

Treatment Details

Interventions

• Bexa Breast Exam

Trial Overview The study tests the effectiveness of the Bexa Breast Exam, which combines a device and focused ultrasound, against digital breast tomosynthesis in detecting breast masses and early signs of cancer.

Participant Groups

Group I: Participants Experimental Treatment 1 Intervention

Participants scheduled for screening mammography.

Bexa Breast Exam is already approved in United States for the following indications:

Approved in United States as Bexa Breast Exam for:

• Documentation of abnormal breast tissues and masses discovered during breast examination

Who Is Running the Clinical Trial?

Sure, Inc.

Lead Sponsor

Trials

3

Recruited

1,400+

Hendrick Medical Center

Collaborator

Trials

2

Recruited

700+

Findings from Research

Breast self-examination (BSE) has a small but measurable effect on the earlier detection of breast cancer, particularly in terms of clinical stage and tumor size, especially when comparing women who perform BSE to those who do not.

To improve the reliability and acceptance of BSE among women over 65, instructions should be simplified, and further research is needed to tailor these instructions and explore the relationship between BSE and earlier cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of breast self-examination. Grady, KE.[2007]

The study found that while breast self-examination (BSE) did not show an overall survival advantage, women who received education on BSE had significantly better survival rates at 13 years compared to those who did not (P < 0.001).

Patients who practiced BSE tended to present with smaller tumors that were more likely to be of better histological grade and lymph node stage, particularly benefiting post-menopausal women, suggesting that BSE can be a useful complement to mammographic screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a seven-year programme of breast self-examination in 89,010 women. Locker, AP., Caseldine, J., Mitchell, AK., et al.[2019]

A study involving 119 Turkish women showed that training on breast self-examination (BSE) significantly improved their knowledge and skills related to breast cancer detection, with a large effect size (Cohen's d = 1.01).

Before the training, 81.5% of the women did not perform BSE regularly, but post-training assessments indicated a marked increase in correct responses regarding breast cancer, its risk factors, and the steps of BSE, highlighting the importance of ongoing education in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Breast Self-examination Training in Turkish Women Living in Northwestern Turkey. Akarsu, NK., Andsoy, II.[2022]

Breast self-examination (BSE) has inconsistent evidence regarding its effectiveness for early detection of breast cancer, with some studies suggesting benefits while others do not.

While the sensitivity and specificity of BSE are not well-defined, educating women on BSE has been shown to improve both the frequency and skill of practice, making it a potentially useful complement to regular clinical examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness, accuracy, and acceptability of breast self-examination as a breast cancer screening method]. Ogawa, H., Tominaga, S., Yoshida, M., et al.[2006]

A study involving 618 women at Çukurova University found that education significantly improved knowledge about breast self-exam (BSE), including its purpose, frequency, and associated risks, which are crucial for early breast cancer detection.

The results suggest that enhancing education on BSE among female healthcare personnel can lead to earlier diagnosis of breast cancer, highlighting the importance of their role in promoting awareness within the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of the knowledge level about breast self-exam among the female employees of a university hospital, Turkey. Şişman, H., Özgen, R., Baysal, D., et al.[2022]

Breast self-examination (BSE) is a crucial method for early detection of breast cancer, with over 90% of cases in American women being discovered by themselves rather than through clinical exams.

Recent clinical trials and surveys from Canada, England, and the United States highlight the importance of BSE, although the effectiveness of routine BSE as a screening tool is still being evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Purposes and goals of breast self-examination. Holleb, AI.[2004]

Only 25% to 35% of American women regularly perform breast self-examinations (BSE), despite the rising incidence of breast cancer, highlighting a gap in self-care practices.

BSE is a crucial technique for early detection of breast cancer that should be taught by nurses to all female patients, especially since mammography may not be accessible to everyone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast self-examination: how nurses can influence performance. Sternberger, C.[2007]

In a study of 405 Thai women aged 30-70, 75.55% reported ever practicing breast self-examination (BSE), and 74.18% had done so in the last 6 months, indicating a relatively high engagement with this screening tool during the COVID-19 pandemic.

Factors such as higher education, younger reproductive age, previous pregnancies, and increased knowledge and positive attitudes towards BSE were significantly associated with the likelihood of practicing BSE, highlighting the need for targeted educational campaigns to improve BSE practices among women with lower awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice, confidence and continuity of breast self-examination among women in Thailand during COVID-19 pandemic: a cross-sectional study. Taneepanichskul, S., Chuemchit, M., Wongsasuluk, P., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The efficacy of breast self-examination. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Results from a seven-year programme of breast self-examination in 89,010 women. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of Breast Self-examination Training in Turkish Women Living in Northwestern Turkey. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

[Effectiveness, accuracy, and acceptability of breast self-examination as a breast cancer screening method]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Measurement of the knowledge level about breast self-exam among the female employees of a university hospital, Turkey. [2022]

6. Israel pubmed.ncbi.nlm.nih.gov

Purposes and goals of breast self-examination. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Breast self-examination: how nurses can influence performance. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Practice, confidence and continuity of breast self-examination among women in Thailand during COVID-19 pandemic: a cross-sectional study. [2023]