Ultrasound-Guided Chemotherapy for Breast Cancer

Overseen By Gregory J Czarnota, PhD, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Inflammatory breast cancer, Pregnancy, Connective tissue disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether ultrasound (an imaging technique using sound waves) can improve chemotherapy delivery for breast cancer patients. Researchers seek to determine if ultrasound can quickly indicate the effectiveness of cancer treatment, allowing doctors to adjust treatments sooner if necessary. The trial will compare two groups: one using ultrasound to guide treatment decisions and another using standard chemotherapy monitoring. This study is suitable for women diagnosed with breast cancer with a primary tumor larger than 2 centimeters and who are eligible for chemotherapy. As an unphased trial, it offers patients the chance to contribute to innovative research that may enhance future breast cancer treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for breast cancer patients?

Research shows that quantitative ultrasound (QUS) is a safe and non-invasive technique. Past studies have used QUS to help detect breast cancer. It creates clear images of breast tissue without requiring surgery or needles.

No major reports of serious side effects from QUS exist, indicating that patients generally tolerate it well. Since other breast cancer studies have used QUS, its safety is well-documented. This makes it a dependable option for assessing treatment effectiveness.

In summary, QUS is considered safe for use in clinical settings. It aids doctors in making better decisions about cancer treatment without harming patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for ultrasound-guided chemotherapy for breast cancer because it offers a novel way to monitor and adapt treatment. Unlike the standard approach that relies on fixed chemotherapy schedules, this method uses quantitative ultrasound to track tumor response in real-time. This could allow doctors to adjust treatment plans early if the cancer isn't responding, potentially improving outcomes and reducing unnecessary side effects. Essentially, this adaptive strategy could make chemotherapy more personalized and effective, leading to better patient care.

What evidence suggests that quantitative ultrasound is effective for guiding chemotherapy in breast cancer?

Research has shown that quantitative ultrasound (QUS), which participants in this trial may undergo, can detect cell death early in breast cancer treatments. This early detection helps doctors switch to more effective therapies sooner. Studies have found that QUS is sensitive enough to identify different types of cell death, such as programmed cell death, death due to injury, and death during cell division. This is important because QUS can detect these changes just days after treatment begins, unlike traditional methods that may take weeks or months. Previous research confirmed that QUS is a reliable tool for monitoring how breast cancer responds to treatment, potentially leading to better outcomes. ^{5 6 7 8 9}

Who Is on the Research Team?

Gregory J Czarnota, PhD, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for women over 18 with breast cancer tumors larger than 2cm who are eligible for chemotherapy. They must have normal liver enzymes, cardiac function, creatinine levels, and blood counts. It's not for those with skin diseases affecting the breast, inflammatory breast cancer, contraindications like pregnancy or past connective tissue disease.

Inclusion Criteria

My breast cancer tumor is larger than 2cm.

I am a woman aged 18 or older.

Your liver enzymes (AST and ALT) should be within a certain range, not too high.

Exclusion Criteria

I do not have severe nerve damage.

My cancer has spread to distant parts of my body.

I need help with my daily activities due to my health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive neoadjuvant chemotherapy guided by quantitative ultrasound or standard neoadjuvant chemotherapy

12 weeks

Visits at Pre-treatment, Weeks 1, 4, 8, 12, and Pre-Operatively

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Quantitative Ultrasound

Trial Overview

The study tests if using quantitative ultrasound (QUS) to monitor cell death can guide adjustments in neoadjuvant chemotherapy more effectively than standard monitoring. The goal is to identify ineffective treatments early and switch to better options quickly.

How Is the Trial Designed?

Group I: Adaptive Chemotherapy Monitoring Experimental Treatment 1 Intervention

Patients who will be randomized to the experimental arm Adaptive Chemotherapy Monitoring and demonstrate Response (+) will continue until standard chemotherapy is completed. For patients who do not demonstrate response after 4 weeks of chemotherapy, an early switch to the second phase of chemotherapy could occur (Phase II/Taxane) At the discretion of the treating medical oncologist. Patients will undergo Quantitative Ultrasound on the following time points: Pre-treatment, Weeks 1, 4, 8, 12 and Pre-Operatively. These QUS time points correspond to the following chemotherapy times.

Group II: Standard Neoadjuvant Chemotherapy Monitoring Active Control 1 Intervention

Patients who will be randomized to the control arm with Standard Neoadjuvant Chemotherapy Monitoring will receive Phase I chemotherapy consisting of anthracycline-based treatment followed by Phase II chemotherapy consisting of taxane-based treatment. Patients will be imaged but no modifications to treatment will occur in this trial arm depending on response by quantitative ultrasound.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

Quantitative ultrasound (QUS) effectively monitored tumor cell death in breast cancer cells treated with hyperthermia (HT) and ultrasound-stimulated microbubbles (USMB), showing significant increases in ultrasound parameters after treatment, particularly at 50 minutes of HT exposure.

The study found a strong correlation between QUS texture features and histopathological findings, indicating that QUS can be a reliable noninvasive imaging technique to assess the effectiveness of anticancer treatments in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Evaluation of Breast Tumor Response to Combined Ultrasound-Stimulated Microbubbles and Hyperthermia Therapy Using Quantitative Ultrasound-Based Texture Analysis Method. Sharma, D., Sannachi, L., Osapoetra, LO., et al.[2023]

Quantitative ultrasound (QUS) imaging can effectively and non-invasively monitor the response of breast cancer patients to chemotherapy, with a study involving 100 patients showing high accuracy in predicting treatment responses.

QUS biomarkers that assess intra-tumour heterogeneity can predict patient outcomes with accuracies ranging from 82% to 89% at different time points after treatment initiation, indicating that this method could help tailor cancer treatments to individual patients based on their early response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy-Response Monitoring of Breast Cancer Patients Using Quantitative Ultrasound-Based Intra-Tumour Heterogeneities. Sadeghi-Naini, A., Sannachi, L., Tadayyon, H., et al.[2020]

Quantitative ultrasound (QUS) parameters can predict tumor response to neoadjuvant chemotherapy (NAC) in locally advanced breast cancer patients, with accuracy improving from 60% at week 1 to 80% at week 4.

Combining pre-treatment QUS data with measurements taken during treatment enhances prediction accuracy and may help tailor personalized treatment plans for patients with refractory tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative ultrasound assessment of breast tumor response to chemotherapy using a multi-parameter approach. Tadayyon, H., Sannachi, L., Gangeh, M., et al.[2023]

Quantitative ultrasound (QUS) can effectively predict recurrence in patients with locally advanced breast cancer during neoadjuvant chemotherapy, with a study of 83 patients showing that the k-NN classifier achieved an accuracy of 81% at week 4.

Incorporating texture derivatives from QUS data significantly improved prediction accuracy, increasing the area under the curve (AUC) from 0.70 to 0.83, indicating that treatment-related changes provide valuable insights for predicting clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Changes in Quantitative Ultrasound Imaging Parameters during Neoadjuvant Chemotherapy to Predict Recurrence in Patients with Locally Advanced Breast Cancer. Bhardwaj, D., Dasgupta, A., DiCenzo, D., et al.[2022]

Quantitative ultrasound (QUS) can effectively predict the response of breast cancer patients to neoadjuvant chemotherapy (NAC) with an impressive accuracy of 88%, based on a study of 56 patients.

QUS features were found to be more effective than molecular markers in predicting patient outcomes, including five-year recurrence-free survival, highlighting its potential as a non-invasive diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A priori Prediction of Neoadjuvant Chemotherapy Response and Survival in Breast Cancer Patients using Quantitative Ultrasound. Tadayyon, H., Sannachi, L., Gangeh, MJ., et al.[2018]

Quantitative ultrasound (QUS) is a promising non-invasive technique that effectively monitors treatment responses by correlating ultrasound backscatter parameters with cell death, making it useful for evaluating tumor responses.

Clinical studies have successfully used QUS to differentiate between benign and malignant breast lesions, as well as to identify patients who respond to treatment, highlighting its potential in improving cancer diagnosis and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Non-Invasive Quantitative Ultrasound in Clinical Cancer Imaging. Sharma, D., Osapoetra, LO., Czarnota, GJ.[2022]

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