Breast Cancer Screening [2022]: What Are We Missing?

Breast Cancer Screening [2022]: What Are We Missing?

Are Women Avoiding Breast Cancer Screening?

Because of COVID-19 and the subsequent lockdowns, a significant number of women were either unable to get their yearly mammograms (primary breast cancer screening tests) or did not feel it was safe to get their regular screening. And why, if they were screened, do such a large number of women still lack a diagnosis? The concept that women with dense breasts are misidentified as having the condition was investigated further through these clinical studies. Screening with mammography according to industry standards is insufficient for early detection, it in fact leads to an increased risk and might cause potential harms.

Will These Trials Shed Some Light On This Breast Cancer Screening Issue?

 

DENSE Phase 4 Clinical Trial

DENSE Trial: MRI breast cancer screening in women 50-75 with dense breast tissue. Extremely high mammographic density increases breast cancer risk four- to six-fold compared to mild density. High mammographic density impairs mammography’s sensitivity, leading to missed diagnoses in many cases. This loses lifesaving data. Mammography is the only screening tool in the Netherlands for high-risk women aged 50 to 75. Magnetic resonance imaging (MRI) has a higher sensitivity than mammography and could improve breast cancer detection in people with high mammographic density. The DENSE trial investigates whether breast cancer screening using MRI is effective in this high-risk group. Participants with large breasts (ACR4) and a negative mammography had “additional MRI” (n = 7,237) or “current practice” (n = 28,948).

 

This is a phase 4 clinical project that is randomized and has an open label. Women who had breast tissue that was very dense and thick were included. Participants had to be between the ages of 50 and 75, have a mammographic density of less than 75%, and a negative result on their most recent mammography (BIRADS 1 or 2). The following is a list of the exceptions to the rule: The presence of intracorporeal metals, a history of adverse reactions to a contrast agent containing gadolinium, markedly reduced renal function (GFR 40 mL/min), women who are pregnant or breastfeeding, claustrophobia, and obesity of more than 150 kilograms.

 

Comparison of Abbreviated Breast MRI and Digital Breast Tomosynthesis Clinical Trial

Women’s breast density screening with abbreviated MRI and digital tomosynthesis mammography. This randomized phase II trial compares digital tomosynthesis mammography and MRI in identifying breast cancer in people with thick breasts. The breast MRI shortened approach uses radio waves and a strong magnet attached to a computer to create detailed images in under ten minutes at a reduced cost.

These images show healthy vs. sick tissue. Digital tomosynthesis mammography combines numerous x-ray images of each breast to create a three-dimensional image. This increases breast cancer detection. Digital tomosynthesis mammography with breast MRI may be more effective for screening women with thick breasts.

 

The validity of invasive tumors found by pathology in participants who underwent screening is the major outcome metric that is being measured. [The length of time could be as long as a year]. The detection rate of invasive malignancies for each modality is defined as the proportion of participants with an invasive cancer detected by the modality at baseline and confirmed by pathology as a percentage of the total number of participants in the study. This proportion is then multiplied by 100 to get the detection rate of invasive malignancies for each modality. This definition is based on the observation that the rate of invasive cancer detection is exactly related to the total number of people who take part in the study. The next table of outcome measures will include an automatic calculation of these proportions, followed by their multiplication by 100 and presentation as percentages (%).

 

Abbreviate or FAST Breast MRI Screening For Black Women at Average Risk and Dense Breasts Clinical Trial

FAST Breast MRI for Breast Cancer Screening in Black Women with Dense Breasts. 500 participants will be randomly selected for a “FAST” breast MRI. Participating women must meet the following criteria: African-Americans 2. Negative DBT test within 11 months of FAST MR Recent mammography shows heterogeneously and highly thick breasts. There are no malignancies, localized thickenings, or clinically significant nipple discharges. Investigators will identify these ladies using the date of their most recent mammogram. Women interested in participating can contact our research coordinators through the recruitment materials. Referring physicians will also receive recruitment information. Doctors can direct patients to the research.

 

SCEMAM Phase 4 Clinical Trial 

Contrast-enhanced mammography vs. MRI for screening (SCEMAM). This study examines CEM’s significance in breast cancer screening. The program aims to promote cancer screening in women with large breasts. MRI detects more cancers than ultrasonography. MRI increases cancer diagnosis and reduces cancer incidence in women with large breasts after a negative screening mammogram. Senate Bill 595 of Pennsylvania, enacted into law on June 30, 2020, requires insurance companies to provide supplemental MRI and ultrasound screenings (breast ultrasounds). The number of women who potentially benefit from screening MRI is low. Over half of women can’t get an MRI due to claustrophobia, implanted gadgets, bodily habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) seems to work like MRI, although it hasn’t been validated for screening. In order to improve screening for women with large breasts, researchers want to offer screening CEM as an alternative to MRI for women who meet screening MRI parameters but cannot undergo MRI.

 

TOCEM Protocol Clinical Trial For Women With Person History of Breast Cancer

Tomosynthesis vs. contrast-enhanced mammography for detecting breast cancer in women with a family history (TOCEM). In a prospective clinical trial, researchers hope to show that contrast-enhanced mammography improves breast cancer detection compared to mammography using tomosynthesis in women with a family history of the disease, with only a minor increase in false positive diagnoses. Invasive tumors without lymph nodes are expected to rise. In this cohort, we’ll additionally test tomosynthesis and CEM alone. This is because one reader will interpret the DBT while another will interpret the CEM. The CEM will conduct three annual screenings. CEM must be conducted within four to six weeks of the annual tomosynthesis mammogram.

 

Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology Clinical Trial

Combining breast MRI and biomarkers to detect high-risk patients (for developing breast cancer). This clinical experiment examines changes in normal breast tissue and MRI that may suggest malignancy. MRI and breast tissue indicators may improve a woman’s breast cancer risk assessment.

Objectives: Count high-risk women with abnormal screening MRIs and normal biopsies across seven years. To explore if WNT10B/mutant p53 expression in a 0-month biopsy can predict cancer in women with an abnormal MRI/noncancerous biopsy over 7 years. Using the C-index, compare WNT10B with MRI against MRI alone to determine its predictive accuracy.

 

Participants get standard-of-care high-risk breast cancer screening MRIs at baseline and during follow-up, as well as baseline blood sample collection. During a breast biopsy or breast surgery, participants submit to the collection of breast tissue samples.

 

Final Thoughts

When this information finally becomes accessible, we will have a better understanding of the situation as a direct result of the ongoing clinical trials that are currently being conducted as well as the passage of time. When advising their patients about breast cancer screenings and providing them with the assistance that will benefit them the most, doctors need to keep this point in mind when they are having conversations with their patients. This should be something to think about, especially since October is Breast Cancer Awareness Month.

 

by Stephanie Comello – OncologyTube

 

References

 

1. ClinicalTrials.gov – Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial. ClinicalTrials.gov, June 8, 2022

2. ClinicalTrials.gov – Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts. ClinicalTrials.gov,  August 18, 2022

3. ClinicalTrials.gov – Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts. ClinicalTrials.gov, June 16, 2022

4. ClinicalTrials.gov – Screening Contrast-Enhanced Mammography as an Alternative to MRI (SCEMAM). ClinicalTrials.gov, September 6, 2022

5. ClinicalTrials.gov – Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania (TOCEM). ClinicalTrials.gov, September 6, 2022

6. ClinicalTrials.gov – Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients. ClinicalTrials.gov, November 24, 2021