What side effects are associated with this type of intervention?

Common treatments for breast cancer include endocrine therapies like tamoxifen and aromatase inhibitors, chemotherapy, and targeted therapies. Tamoxifen can cause hot flashes, nausea, fatigue, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, such as anastrozole, are associated with loss of bone density, fractures, and cardiovascular risks. Chemotherapy often leads to side effects like hair loss, nausea, fatigue, and increased susceptibility to infections. Targeted therapies, such as HER2 inhibitors, can cause diarrhea, fatigue, and cardiac issues. Each treatment has a unique side effect profile that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA approvals for breast cancer treatment have included a variety of drugs and therapies. Notably, treatments such as trastuzumab (Herceptin) and pertuzumab (Perjeta) have been approved for HER2-positive breast cancer. Additionally, immune checkpoint inhibitors like pembrolizumab (Keytruda) have been approved for certain types of breast cancer. While specific FDA approvals for enhanced imaging techniques like Contrast Enhanced Ultrasound (CEUS) in breast cancer are not detailed, these imaging methods are being studied to potentially improve early detection and treatment response monitoring.

What other types of research exist?

Promising novel alternatives to CEUS for breast cancer patients include: 1) Magnetic Resonance Imaging (MRI), particularly with advanced techniques like diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI), which offer high sensitivity and specificity. 2) Positron Emission Tomography/Computed Tomography (PET/CT) using novel tracers such as fluorodeoxyglucose (FDG) for metabolic imaging. 3) Molecular Breast Imaging (MBI), which uses gamma cameras and radiotracers to detect tumors. These methods provide detailed anatomical and functional information, aiding in early detection and treatment response monitoring.

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CEUS to Predict Treatment Response in Breast Cancer

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

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Endocrine therapy targets hormone receptor-positive breast cancers by blocking hormones like estrogen that fuel cancer growth. Targeted therapies, such as HER2-directed treatments (e.g., trastuzumab), specifically target the HER2 protein overexpressed in some breast cancers, inhibiting cell proliferation. These mechanisms are crucial for personalizing treatment plans and improving outcomes. Enhanced imaging techniques like Contrast Enhanced Ultrasound (CEUS) can help in early detection of treatment response, allowing for timely adjustments to therapy and potentially better prognoses.

Phase < 1

Recruiting

Led By Seth Hardy, M.D.

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Age greater than 18yo

Stage I-III TNBC or stage IV TNBC with intact breast primary

Must not have

Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a special type of ultrasound called contrast enhanced ultrasound (CEUS) can show if patients with aggressive breast cancer are responding to treatment faster than traditional scans. The target group is patients with triple negative breast cancer who are receiving a combination of immune therapies. CEUS uses a special dye to make the images clearer, helping doctors see changes in the tumor more quickly.

Who is the study for?

This trial is for adults over 18 with Stage I-III Triple Negative Breast Cancer (TNBC) or stage IV TNBC who still have the primary breast tumor. They must be willing to follow study procedures and receive combined Immune Checkpoint Inhibitors therapy as standard care. Pregnant women, those allergic to eggs, or with past reactions to ultrasound contrast agents like PEG can't participate.

What is being tested?

The study is testing if Contrast Enhanced Ultrasound (CEUS), using a contrast agent called Lumason, can predict how well TNBC patients respond to chemotherapy and immune checkpoint inhibitors sooner than current methods like MR or CT scans.

What are the potential side effects?

Potential side effects from Lumason may include allergic reactions in individuals sensitive to eggs or PEG due to its components. However, this pilot study primarily focuses on the diagnostic capability of CEUS rather than treatment side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Select...

My breast cancer is at an early or locally advanced stage, or it's spread but the primary tumor is still in my breast.

Exclusion Criteria

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

Select...

I am not pregnant, allergic to eggs, or have had reactions to ultrasound contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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 Ultrasound (with Lumason)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumason

2015

Completed Phase 4

~400

0 / 3Eligibility 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

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Endocrine therapy targets hormone receptor-positive breast cancers by blocking hormones like estrogen that fuel cancer growth. Targeted therapies, such as HER2-directed treatments (e.g., trastuzumab), specifically target the HER2 protein overexpressed in some breast cancers, inhibiting cell proliferation. These mechanisms are crucial for personalizing treatment plans and improving outcomes. Enhanced imaging techniques like Contrast Enhanced Ultrasound (CEUS) can help in early detection of treatment response, allowing for timely adjustments to therapy and potentially better prognoses.

Mutational landscape implicates epithelial-mesenchymal transition gene TGF-β2 mutations for uterine carcinosarcoma after adjuvant tamoxifen therapy for breast carcinoma.New concepts in breast cancer therapy.