Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
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ClinicalTrials.gov Identifier: NCT04050228 |
Recruitment Status :
Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Other: Imaging | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Phase 2 Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer |
Actual Study Start Date : | June 13, 2018 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
---|---|
No Intervention: Standard Neoadjuvant Chemotherapy Monitoring | |
Experimental: Adaptive Chemotherapy Monitoring |
Other: Imaging
Patient in the control arm will receive standard neoadjuvant chemotherapy and clinical monitoring as per standard of care. Patients will be imaged but no modifications to treatment will occur in this trial arm depending on response by quantitative ultrasound. Patients in the experimental arm will receive adaptive neoadjuvant chemotherapy based on quantitative ultrasound monitoring. Non-responders to neoadjuvant chemotherapy based on quantitative ultrasound will be switched to different chemotherapy or other treatments reflecting current clinical practice. The treatment option will be left to the discretion of the treating medical oncologist and the care team. |
- Measuring the rate of treatment response between the treatment groups [ Time Frame: Up to 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Women ≥ 18 years of age with breast cancer eligible for neoadjuvant chemotherapy |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050228
Contact: Gregory J Czarnota, PhD, MD | (416) 480-6128 | gregory.czarnota@sunnybrook.ca |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Gregory J Czarnota, PhD, MD (416) 480-6128 gregory.czarnota@sunnybrook.ca | |
Principal Investigator: Maureen E Trudeau, MD |
Responsible Party: | Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT04050228 |
Other Study ID Numbers: |
308-2017 |
First Posted: | August 8, 2019 Key Record Dates |
Last Update Posted: | August 8, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ultrasound, Chemotherapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |