Recruiting

Integrated Patient Avatars

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04608357

Conditions

Breast Cancer

Breast Neoplasms

Metastatic Breast Cancer

Cancer, Breast

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Needle Core Biopsies

Study Details

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

Study ID

NCT04608357

Start date

Jul 21, 2021

Status verified date

Jan, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Needle Core Biopsies

Not an interventional study

Primary outcome measure

  • Determine the tumor take rate in PDX [ Time Frame: 7-10 days ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 20, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-01-20.