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

NCT04608357 | Recruiting

• 1 other identifier: SUN-2252
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Metastatic Breast Cancer; Cancer, Breast

Keywords

metastatic breast cancer; systemic therapy; needle core biopsy; PDXovo; feasibility study; tumor take rate

Outcome Measures

Primary Outcomes (1)

• 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

  7-10 days

Secondary Outcomes (1)

• Compare response rates of PDXs & with that of the patient from whom the PDX was derived

  8 to 16 weeks

Interventions

Needle Core Biopsies DIAGNOSTIC_TEST

Not an interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• AFP Innovation Fund: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38969866 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

needle core biopsies

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Katarzyna J Jerzak, MD MSc FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna J Jerzak, MD MSc FRCPC

CONTACT

416-480-6100; katarzyna.jerzak@sunnybrook.ca

Hon S Leong

CONTACT

416-480-6100; hon.leong@sri.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist & Associate Scientist

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: July 21, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CA (1)