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Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients

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: NCT04608357
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
AFP Innovation Fund
Information provided by (Responsible Party):
Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre

Brief Summary:
The investigators propose to use clinically validated patient avatar technology ("PDXovo") that can test multiple drugs against patients' cancers to identify the most promising systemic therapy for each individual.

Condition or disease Intervention/treatment
Breast Cancer Breast Neoplasms Metastatic Breast Cancer Cancer, Breast Diagnostic Test: Needle Core Biopsies

Detailed Description:

The primary goal of this feasibility study is to determine the percentage of patients for whom PDXs are successfully generated within 7-10 days. This will give the investigators an indication of the success rate for providing patients with actionable information if this PDX technology were to be implemented in the clinic. Since the PDXs will also receive the same drug as the patient, there is an opportunity to assess the agreement between the clinical response and the PDX response.

As a secondary goal, the response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate at 12 weeks +/- 4 weeks (ORR, measured using RECIST 1.1 criteria).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
Actual Study Start Date : July 21, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Needle Core Biopsies
    Not an interventional study


Primary Outcome Measures :
  1. Determine the tumor take rate in PDX [ Time Frame: 7-10 days ]
    perform a feasibility study to determine the tumor take rate(s) in PDXs generated from needle core biopsies collected from metastatic breast cancer patients


Secondary Outcome Measures :
  1. Compare response rates of PDXs & with that of the patient from whom the PDX was derived [ Time Frame: 8 to 16 weeks ]
    The response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate.


Biospecimen Retention:   Samples With DNA
needle core biopsies


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy
Criteria

Inclusion Criteria:

  1. Age 18+.
  2. Metastatic breast cancer irrespective of subtype.
  3. Measurable disease as per RECIST 1.1 criteria.
  4. Metastatic disease involving the lymph nodes and/or visceral organs is required.
  5. Willingness to undergo a biopsy prior to the start of planned systemic therapy.

Exclusion Criteria:

  1. Lack of feasibility to obtain a core biopsy of a metastatic site other than the bone (e.g. a metastatic lesion cannot be safely sampled due to proximity to vasculature).
  2. Inability to provide informed consent.

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): NCT04608357


Contacts
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Contact: Katarzyna J Jerzak, MD MSc FRCPC 416-480-6100 ext 5248 katarzyna.jerzak@sunnybrook.ca
Contact: Hon S Leong 416-480-6100 ext 5748 hon.leong@sri.utoronto.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Katarzyna J Jerzak, MD MSc FRCPC    416-480-6100 ext 5248    katarzyna.jerzak@sunnybrook.ca   
Contact: Hon S Leong    416-480-6100 ext 5748    hon.leong@sri.utoronto.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
AFP Innovation Fund
Investigators
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Principal Investigator: Katarzyna J Jerzak, MD MSc FRCPC Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Katarzyna Jerzak, Medical Oncologist & Associate Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04608357    
Other Study ID Numbers: SUN-2252
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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. Katarzyna Jerzak, Sunnybrook Health Sciences Centre:
metastatic breast cancer
systemic therapy
needle core biopsy
PDXovo
feasibility study
tumor take rate
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases