What side effects are associated with this type of intervention?

Common treatments for breast cancer include surgery, radiation therapy, chemotherapy, and endocrine therapy. Surgery can lead to pain, infection, and lymphedema. Radiation therapy often causes skin irritation, fatigue, and breast pain. Chemotherapy is associated with nausea, hair loss, fatigue, and increased infection risk. Endocrine therapy, such as tamoxifen, can cause hot flashes, fatigue, and an increased risk of blood clots. For imaging techniques like Contrast-Enhanced Mammography (CEM) that use iodinated contrast, potential side effects include allergic reactions and nephrotoxicity, particularly in patients with pre-existing kidney conditions.

What prior FDA approvals exist?

FDA approvals for breast cancer treatments have included various targeted therapies and monoclonal antibodies, such as trastuzumab and its biosimilars, which target HER2-positive breast cancer. These treatments have significantly improved outcomes in both early and metastatic settings. Additionally, newer imaging techniques like Contrast-Enhanced Mammography (CEM) are being studied as alternatives to MRI for breast cancer screening, utilizing iodinated contrast to enhance imaging. This approach aims to provide a viable option for patients who cannot undergo MRI due to various constraints.

What other types of research exist?

Promising alternatives to Contrast-Enhanced Mammography (CEM) for breast cancer screening include: 1) Contrast-Enhanced Ultrasound (CEUS): Utilizes microbubble contrast agents and has shown efficacy in differentiating benign from malignant breast lesions. 2) Magnetic Resonance Imaging (MRI): Particularly with gadobenate dimeglumine, MRI has demonstrated higher sensitivity and diagnostic accuracy compared to traditional methods. 3) Machine Learning and Radiomics: Integrative frameworks combining CEUS with machine learning for enhanced diagnostic accuracy. These alternatives offer varying benefits such as reduced radiation exposure, higher sensitivity, and advanced diagnostic capabilities.

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Contrast-Enhanced Mammography for Breast Cancer Screening (SCEMAM Trial)

Phase 4

Waitlist Available

Led By Wendie Berg, MD, PhD

Research Sponsored by Wendie Berg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing contrast-enhanced mammography (CEM) as an alternative for women who need a breast MRI but can't get one. CEM uses a special dye with regular mammogram machines to make cancer spots more visible. The goal is to improve breast cancer detection in women who can't have an MRI. CEM combines conventional mammography with iodinated contrast material to improve cancer detection.

Who is the study for?

This trial is for women aged 30-75 with dense breasts or high breast cancer risk due to genetics, family history, or past chest radiation. It's also for those recommended for MRI screening but can't have it due to factors like claustrophobia or implants. Women with a personal history of early breast cancer are eligible too. Exclusions include current breast symptoms, poor kidney function, active chemotherapy (except oral endocrine therapy), having breast implants, being under 30 or over 75 years old, and recent pregnancy/breastfeeding or breast surgery.

What is being tested?

The study tests if contrast-enhanced mammography (CEM) can be an alternative to MRI for breast cancer screening in women who cannot undergo MRI. CEM uses standard mammography equipment plus an intravenous iodinated contrast agent similar to what's used in CT scans.

What are the potential side effects?

Potential side effects may include reactions to the iodinated contrast media such as allergic reactions ranging from mild itching to severe responses like difficulty breathing; kidney issues especially if pre-existing conditions are present; and discomfort from the procedure itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cancer Detection Rate

Secondary study objectives

False Positive Recall Rates

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast-enhanced mammographyExperimental Treatment2 Interventions

Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes the tumor, while radiation therapy uses high-energy rays to destroy cancer cells. Chemotherapy employs cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Endocrine therapy blocks hormones like estrogen that fuel certain breast cancers, and targeted therapies, such as HER2 inhibitors, specifically attack cancer cells with particular genetic markers. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan. Imaging techniques like Contrast-Enhanced Mammography (CEM) enhance the detection and monitoring of breast cancer, ensuring timely and accurate treatment adjustments.

[Primary and adjuvant treatment of breast cancer: an update].Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial.Radiotherapy for early breast cancer.