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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050228
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Imaging Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Measuring the rate of treatment response between the treatment groups [ Time Frame: Up to 5 years ]

Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Gregory J Czarnota, PhD, MD (416) 480-6128 gregory.czarnota@sunnybrook.ca

Locations
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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         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre:
Ultrasound, Chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases