What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as tamoxifen and aromatase inhibitors, have known side effects. Tamoxifen can cause hot flashes, increased risk of blood clots, and endometrial cancer. Aromatase inhibitors may lead to bone density loss, fractures, and cardiovascular risks. Gadolinium-based contrast agents used in imaging can cause allergic reactions and, rarely, nephrogenic systemic fibrosis in patients with severe renal dysfunction. Chemotherapy often results in nausea, hair loss, and fatigue, while radiation therapy can cause skin irritation and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including hormone therapies, chemotherapy, targeted therapies, and immunotherapies. Notable drugs include trastuzumab (Herceptin) for HER2-positive breast cancer, tamoxifen for hormone receptor-positive breast cancer, and palbociclib (Ibrance) for advanced or metastatic breast cancer. While these treatments are not directly related to contrast-enhanced mammography, they represent the range of therapeutic options available for breast cancer management. CEM itself is a diagnostic advancement aimed at improving the detection and monitoring of breast cancer.

What other types of research exist?

Promising novel alternatives to Contrast-Enhanced Mammography for breast cancer patients include: 1) Digital Breast Tomosynthesis (3D Mammography), which provides a three-dimensional image of the breast and has been shown to improve cancer detection rates. 2) Breast MRI, particularly with advanced techniques like diffusion-weighted imaging and dynamic contrast-enhanced MRI, which offer high sensitivity in detecting breast cancer and differentiating between benign and malignant lesions. 3) Molecular Breast Imaging (MBI), which uses a radioactive tracer and specialized camera to detect cancer cells, showing promise in women with dense breast tissue. 4) Automated Breast Ultrasound (ABUS), which provides a comprehensive view of the entire breast and is particularly useful for women with dense breasts.

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Biennial CEM Screening for Breast Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for breast cancer include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery involves removing the tumor, while radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy employs drugs to destroy rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that can promote cancer growth, and targeted therapy uses drugs to target specific molecules involved in cancer cell growth and survival. Contrast-enhanced mammography (CEM) enhances the visibility of breast tissues using contrast agents, improving the detection of abnormalities. These treatments are crucial for breast cancer patients as they offer multiple strategies to eliminate cancer cells, reduce recurrence, and improve survival rates.

N/A

Recruiting

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

Must not have

Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 45 mL/min

Women who have had bilateral mastectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 months, 48 months, and 62 months

Awards & highlights

Summary

This trial is testing if adding a special type of mammogram with a contrast dye to the regular 3D mammogram can better detect breast cancer in women who have had it before. The dye helps highlight cancerous areas, and the 3D images provide detailed views from different angles.

Who is the study for?

This trial is for asymptomatic women aged 30-79 with a history of breast cancer, at least one year post any breast cancer surgery or treatment, and scheduled for an annual mammogram. Excluded are those with stage 4 metastasis to certain areas, bilateral mastectomy, recent chemotherapy or MRI exams, implants in the breasts to be screened, kidney issues including failure or low filtration rate, pregnancy or lactation, single kidney possession, and severe iodinated contrast reactions.

What is being tested?

The study is testing if adding biennial contrast-enhanced mammography (CEM) to annual 3D mammography improves detection rates of breast cancer without significantly increasing false positives among women who have previously had breast cancer.

What are the potential side effects?

Potential side effects may include allergic reactions to the iodinated contrast used in CEM. Women with mild allergies can participate if pre-medicated but will be excluded if they're allergic to common pre-medications like Benadryl.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman with kidney issues or my kidney filtering rate is below 45 mL/min.

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I have had both of my breasts surgically removed.

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My cancer has spread to my organs or brain.

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I am a woman currently undergoing chemotherapy for cancer.

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I have only one kidney.

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I do not have breast implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 months, 48 months, and 62 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 months, 48 months, and 62 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months, 48 months, and 62 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

False-positive recall rate

Incremental Cancer Detection Rate

Positive-predictive values

Trial Design

1Treatment groups

Experimental Treatment

Group I: contrast-enhanced mammographyExperimental Treatment1 Intervention

Enrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care.

0 / 6Eligibility criteria met

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

Common treatments for breast cancer include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery involves removing the tumor, while radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy employs drugs to destroy rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that can promote cancer growth, and targeted therapy uses drugs to target specific molecules involved in cancer cell growth and survival. Contrast-enhanced mammography (CEM) enhances the visibility of breast tissues using contrast agents, improving the detection of abnormalities. These treatments are crucial for breast cancer patients as they offer multiple strategies to eliminate cancer cells, reduce recurrence, and improve survival rates.

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Who is running the clinical trial?

Wendie BergLead Sponsor

3 Previous Clinical Trials

8,514 Total Patients Enrolled

3 Trials studying Breast Cancer

8,514 Patients Enrolled for Breast Cancer

Breast Cancer Research FoundationOTHER

70 Previous Clinical Trials

136,261 Total Patients Enrolled

41 Trials studying Breast Cancer

128,977 Patients Enrolled for Breast Cancer

Wendie Berg, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh

3 Previous Clinical Trials

8,514 Total Patients Enrolled

3 Trials studying Breast Cancer

8,514 Patients Enrolled for Breast Cancer

~1000 spots leftby Dec 2029

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