Testing personalized cancer treatments using patient-derived tumors in mice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves obtaining clinical specimens from patients with triple negative breast cancer, colorectal cancer, and high-grade serous ovarian cancer to create personalized patient-derived xenografts (pPDX) in mice. These pPDX models will be used to conduct molecular profiling and drug sensitivity testing to identify effective treatment options tailored to the individual patient. The goal is to enhance clinical decision-making by correlating the drug responses observed in the pPDX with the actual responses of the patients to therapy. This approach aims to bridge the gap between pre-clinical models and clinical management of cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years.
2. Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):

   (I) Histologically confirmed Triple Negative Breast Cancer by Institutional and American Society of Clinical Oncology (ASCO)/Cancer of American Pathologists (CAP) guidelines, either:
   * Stage IV (metastatic) disease that has not been treated with systemic therapy in the metastatic setting or
   * Stage I to III (non-metastatic) with residual mass by clinical exam and/or breast imaging following anthracycline + taxane-containing neoadjuvant chemotherapy

   OR

   (II) Histologically-confirmed Stage IV colorectal cancer treated with ≤ 1 line of systemic therapy in the metastatic setting, either:
   * Undergoing surgical resection of liver metastases or
   * With metastatic lesions amenable to biopsy

   OR

   (III) Histologically-confirmed advanced High Grade Serous Ovarian Cancer, either:
   * Recurrent disease with a life expectancy of at least 12 months or
   * Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence

   OR

   (IV) Histologically confirmed solid tumor not meeting criteria for (I), (II) or (III) above, for which evaluation of investigational therapies is of particular interest or where clinical need exists, at the discretion of the PI
3. Disease amenable to biopsy or surgery for tissue procurement
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion Criteria:

1. Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials.
2. Known brain metastasis
3. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
4. Any contraindication to undergoing a biopsy procedure.

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: David Cescon, MD — Princess Margaret Cancer Centre
• Study coordinator: David Cescon, MD
• Email: Dave.Cescon@uhn.ca
• Phone: 416-946-2245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.