← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My breast cancer tumor is larger than 2cm.

Select...

I am eligible for chemotherapy before surgery.

Select...

My condition qualifies for chemotherapy.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measuring the rate of treatment response between the treatment groups

Secondary outcome measures

Clinical efficacy of quantitative ultrasound

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,068 Total Patients Enrolled

29 Trials studying Breast Cancer

16,656 Patients Enrolled for Breast Cancer

Gregory J Czarnota, PhD, MDPrincipal InvestigatorSunnybrook Health Sciences Centre

6 Previous Clinical Trials

1,770 Total Patients Enrolled

4 Trials studying Breast Cancer

1,700 Patients Enrolled for Breast Cancer

Media Library

Adaptive Chemotherapy Monitoring Clinical Trial Eligibility Overview. Trial Name: NCT04050228 — N/A

Breast Cancer Research Study Groups: Adaptive Chemotherapy Monitoring, Standard Neoadjuvant Chemotherapy Monitoring

Breast Cancer Clinical Trial 2023: Adaptive Chemotherapy Monitoring Highlights & Side Effects. Trial Name: NCT04050228 — N/A

Adaptive Chemotherapy Monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT04050228 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still accepting participants?

"As per clinicaltrials.gov, this experiment is presently recruiting subjects and was initially made available on June 13th 2018 with its last revision occurring on October 5th 2022."

Answered by AI

How many participants are contributing to this research endeavor?

"Affirmative. Information available on clinicaltrials.gov states that the research project, initially posted on June 13th 2018 is still actively enrolling participants. The trial seeks to recruit 120 patients from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer

Dr. Gregory Czarnota 2018. "Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04050228.