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Ultrasound-Guided Chemotherapy for Breast Cancer

N/A

Recruiting

Led By Gregory J Czarnota, PhD, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Diagnosis of breast cancer with a primary tumour >2cm in size

Eligible for neoadjuvant chemotherapy

Must not have

No peripheral neuropathy of a severity of grade ≥2

Evidence of distant metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using ultrasound to guide chemotherapy treatment is more effective than the standard clinical approach.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial focuses on imaging rather than drugs, typical side effects of neoadjuvant chemotherapy may include nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts and potential heart or kidney issues.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer tumor is larger than 2cm.

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I am eligible for chemotherapy before surgery.

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My condition qualifies for chemotherapy.

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My heart pumps well, with an ejection fraction of 55% or higher.

Exclusion Criteria

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

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I do not have severe nerve damage.

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My cancer has spread to distant parts of my body.

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

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I have inflammatory breast cancer.

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I am not pregnant or breastfeeding.

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I have a history of connective tissue disease.

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I have had skin conditions affecting my breast.

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

Study Objectives

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

Primary study objectives

Measuring the rate of treatment response between the treatment groups

Secondary study objectives

Clinical efficacy of quantitative ultrasound

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive Chemotherapy MonitoringExperimental Treatment1 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 MonitoringActive Control1 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.

0 / 11Eligibility criteria met