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NCT Number: NCT04608357

Integrated Patient Avatars for Guiding Systemic Therapy Treatments 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Needle Core Biopsies

Diagnostic Test

Not an interventional study

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hon S Leong

CONTACT

[email protected]

416-480-6100 ext. 5748

Katarzyna J Jerzak, MD MSc FRCPC

CONTACT

[email protected]

416-480-6100 ext. 5248

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • AFP Innovation Fund

Registry information

Official study title

Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 29, 2020
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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