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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04050228
• Other study ID #: 308-2017
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: June 2029

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Gregory J Czarnota, PhD, MD
• Phone: (416) 480-6128
• Email: gregory.czarnota[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2029
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women = 18 years of age

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

3. With conditions meeting criteria for chemotherapy administration

4. Normal hematological blood counts (hemoglobin = 100 g/l, platelet count = 100 x 109, absolute neutrophil count = 2.0 x109 cells per L)

5. Creatinine =175 µmol/L

6. Liver enzymes (AST and ALT) = 1.5 times upper limit of normal

7. Cardiac function (left ventricular ejection fraction) =55%

8. Eligible for neoadjuvant chemotherapy.

Exclusion Criteria:

1. Inflammatory breast cancer

2. Contraindications to neoadjuvant treatment including pregnancy or lactation

3. Past medical history of connective tissue disease

4. Past history of dermatologic disease involving the breast

5. Eastern Cooperative Group Status (ECOG) =3

6. No peripheral neuropathy of a severity of grade =2

7. Evidence of distant metastatic disease

8. Known sensitivity to components present in ultrasound gel.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical efficacy of quantitative ultrasound	Sensitivity and specificity of quantitative ultrasound will be calculated against surgical pathologic response documented after surgery.	Up to 5 years