Breast CancerNCT04608357
Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
An observational study of Breast Cancer and Breast Neoplasms, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Metastatic Breast Cancer
- What is being tested?
- Needle Core Biopsies
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jul 2021to Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy
Who may be able to join
- Age 18+.
- Metastatic breast cancer irrespective of subtype.
- Measurable disease as per RECIST 1.1 criteria.
- Metastatic disease involving the lymph nodes and/or visceral organs is required.
- Willingness to undergo a biopsy prior to the start of planned systemic therapy.
Who cannot join
- 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).
- Inability to provide informed consent.
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
Katarzyna J Jerzak, MD MSc FRCPC, 416-480-6100 ext. 5248, katarzyna.jerzak@sunnybrook.ca
Hon S Leong, 416-480-6100 ext. 5748, hon.leong@sri.utoronto.ca
About this study
Official title: Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
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.
Read the 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).
- Being tested
- Needle Core Biopsies
- Keywords
- metastatic breast cancer, systemic therapy, needle core biopsy, PDXovo, feasibility study, tumor take rate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle Core BiopsiesDiagnostic test
Not an interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the tumor take rate in PDX
perform a feasibility study to determine the tumor take rate(s) in PDXs generated from needle core biopsies collected from metastatic breast cancer patients
Measured: 7-10 days
Secondary outcomes (1)
Compare response rates of PDXs & with that of the patient from whom the PDX was derived
The response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate.
Measured: 8 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start21 Jul 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund
- Responsible party
- Principal investigator, Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre
- Investigators
- Katarzyna J Jerzak, MD MSc FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608357
- Sponsor's protocol ID
- SUN-2252
- Status last verified
- Jan 2025
- First submitted
- 23 Oct 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grafinger OR, Hayward JJ, Meng Y, Geddes-McAlister J, Li Y, Mar S, Sheng M, Su B, Thillainadesan G, Lipsman N, Coppolino MG, Trant JF, Jerzak KJ, Leong HS. Cancer cell extravasation requires iplectin-mediated delivery of MT1-MMP at invadopodia. Br J Cancer. 2024 Sep;131(5):931-943. doi: 10.1038/s41416-024-02782-9. Epub 2024 Jul 5.
PubMed 38969866
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04608357
- Acronym / sponsor ID
- SUN-2252
- Keywords
- metastatic breast cancer, systemic therapy, needle core biopsy, PDXovo, feasibility study, tumor take rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- AFP Innovation Fund
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2020 (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 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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy
Key inclusion criteria (5 listed)
- Age 18+.
- Metastatic breast cancer irrespective of subtype.
- Measurable disease as per RECIST 1.1 criteria.
- Metastatic disease involving the lymph nodes and/or visceral organs is required.
- Willingness to undergo a biopsy prior to the start of planned systemic therapy.
Key exclusion criteria (2 listed)
- 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).
- Inability to provide informed consent.
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 |
|---|---|---|
| Needle Core BiopsiesNot an interventional study | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Compare response rates of PDXs & with that of the patient from whom the PDX was derived
Time frame: 8 to 16 weeks
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 20 Jan 2025.
- Derived from this study: PubMed 38969866Grafinger OR, Hayward JJ, Meng Y, Geddes-McAlister J, Li Y, Mar S, Sheng M, Su B, Thillainadesan G, Lipsman N, Coppolino MG, Trant JF, Jerzak KJ, Leong HS. Cancer cell extravasation requires iplectin-mediated delivery of MT1-MMP at invadopodia. Br J Cancer. 2024 Sep;131(5):931-943. doi: 10.1038/s41416-024-02782-9. Epub 2024 Jul 5.
- Individual participant dataSharing planned: Undecided
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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.
Katarzyna J Jerzak, MD MSc FRCPC 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?
An observational study of Breast Cancer and Breast Neoplasms, 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 5 inclusion and 2 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 20 Jan 2025. 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 Katarzyna J Jerzak, MD MSc FRCPC (416-480-6100 ext. 5248, katarzyna.jerzak@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the tumor take rate in PDX (time frame: 7-10 days). 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 NCT04608357, which also lists 1 linked publication.
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 20 Jan 2025.