NCT04050228

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

A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound (QUS), which is non-invasive, inexpensive and portable.

Detailed description

This study phase II will demonstrate the use of quantitative ultrasound to guide adaptive chemotherapy for patients with breast cancer. The primary endpoint will be measurement of improved response rate locally. This trial will enroll 240 randomized breast cancer patients to be assess with quantitative ultrasound to guide adaptive neoadjuvant chemotherapy as compared to standard clinical monitoring and therapy. We will evaluate the safety of its use and expect equivalence in this small patient population. This will allow for more accurate estimation of a needed sample size for a phase III superiority trial.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Quantitative ultrasound to guide adaptive chemotherapy	Quantitative ultrasound results will be used to measure chemotherapy response and guide an adaptive chemotherapy strategy for patients who are found to be nonresponders to their chemotherapy.

Timeline

• Start date: 2018-06-13
• Primary completion: 2025-06-01
• Completion: 2029-06-01
• First posted: 2019-08-08
• Last updated: 2023-12-28

Locations

1 site across 1 country: Canada