Clinical trial NCT04050228: Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
Official title: A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Ultrasound, Chemotherapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring the rate of treatment response between the treatment groups
timeFrame: Up to 5 years
Secondary outcomes:
measure: Clinical efficacy of quantitative ultrasound
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gregory J Czarnota, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: