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

NCT04050228 | Recruiting

• 1 other identifier: 308-2017
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Ultrasound, Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Measuring the rate of treatment response between the treatment groups

  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.

  Up to 5 years

Secondary Outcomes (1)

• Clinical efficacy of quantitative ultrasound

  Up to 5 years

Study Arms (2)

Standard Neoadjuvant Chemotherapy Monitoring

NO 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.

Adaptive Chemotherapy Monitoring

EXPERIMENTAL

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.

Device: Quantitative ultrasound to guide adaptive chemotherapy

Interventions

Quantitative ultrasound to guide adaptive chemotherapy DEVICE

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.

Adaptive Chemotherapy Monitoring

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women ≥ 18 years of age with breast cancer eligible for neoadjuvant chemotherapy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years of age
• Diagnosis of breast cancer with a primary tumour \>2cm in size
• With conditions meeting criteria for chemotherapy administration
• Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
• Creatinine ≤175 µmol/L
• Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
• Cardiac function (left ventricular ejection fraction) ≥55%
• Eligible for neoadjuvant chemotherapy.

You may not qualify if:

• Inflammatory breast cancer
• Contraindications to neoadjuvant treatment including pregnancy or lactation
• Past medical history of connective tissue disease
• Past history of dermatologic disease involving the breast
• Eastern Cooperative Group Status (ECOG) ≥3
• No peripheral neuropathy of a severity of grade ≥2
• Evidence of distant metastatic disease
• Known sensitivity to components present in ultrasound gel.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (2)

• Moore-Palhares D, Alberico D, Chan AW, DiCenzo D, Sannachi L, Dasgupta A, Yip J, Pena MLA, Gandhi S, Pezo R, Eisen A, Jerzak KJ, Gonzalez CAC, Warner E, Wright FC, Look-Hong N, Roberts A, Sadeghi-Naini A, Curpen B, Skarpathiotakis M, Betel C, Kolios MC, Trudeau M, Czarnota GJ. Quantitative ultrasound imaging for predicting response and guiding personalized neoadjuvant chemotherapy in breast cancer: randomized phase 2 clinical trial results. NPJ Precis Oncol. 2025 Dec 4;9(1):390. doi: 10.1038/s41698-025-01134-x.

  PMID: 41345775 DERIVED

• Dasgupta A, DiCenzo D, Sannachi L, Gandhi S, Pezo RC, Eisen A, Warner E, Wright FC, Look-Hong N, Sadeghi-Naini A, Curpen B, Kolios MC, Trudeau M, Czarnota GJ. Quantitative ultrasound radiomics guided adaptive neoadjuvant chemotherapy in breast cancer: early results from a randomized feasibility study. Front Oncol. 2024 Apr 19;14:1273437. doi: 10.3389/fonc.2024.1273437. eCollection 2024.

  PMID: 38706611 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

CONTACT

(416) 480-6128; gregory.czarnota@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Clinician Scientist

Model Details: The trial design is a Phase II study to 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. Patients were randomly allocated in 1:1 ratio to a standard arm or experimental arm stratified by hormonal receptor status

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 8, 2019
• Study Start: June 13, 2018
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CA (1)