Breast CancerNCT04050228
Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
A study testing Quantitative ultrasound to guide adaptive chemotherapy in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Quantitative ultrasound to guide adaptive chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jun 2018to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Gregory J Czarnota, PhD, MD, (416) 480-6128, gregory.czarnota@sunnybrook.ca
Maureen E Trudeau, MD
About this study
Official title: A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)
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.
Read the 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
- Being tested
- Quantitative ultrasound to guide adaptive chemotherapy
- Keywords
- Ultrasound, Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative ultrasound to guide adaptive chemotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Quantitative ultrasound to guide adaptive chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (1)
Clinical efficacy of quantitative ultrasound
Sensitivity and specificity of quantitative ultrasound will be calculated against surgical pathologic response documented after surgery.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start13 Jun 2018
- Primary completionJun 2025 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- Gregory J Czarnota, PhD, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050228
- Sponsor's protocol ID
- 308-2017
- Status last verified
- Dec 2023
- First submitted
- 22 Jul 2019
- Last updated
- 28 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41345775Dasgupta 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.
PubMed 38706611
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)
- ClinicalTrials.gov ID
- NCT04050228
- Acronym / sponsor ID
- 308-2017
- Conditions
- Breast Cancer
- Keywords
- Ultrasound, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Quantitative ultrasound to guide adaptive chemotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative ultrasound to guide adaptive chemotherapyQuantitative 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. | Device | Adaptive Chemotherapy Monitoring |
Primary outcome
Measuring the rate of treatment response between the treatment groups
Time frame: Up to 5 years
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.
1 secondary outcome
Clinical efficacy of quantitative ultrasound
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 41345775Moore-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.
- Derived from this study: PubMed 38706611Dasgupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory J Czarnota, PhD, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative ultrasound to guide adaptive chemotherapy in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory J Czarnota, PhD, MD ((416) 480-6128, gregory.czarnota@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the rate of treatment response between the treatment groups (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050228, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.