Recruiting

pPDX Modeling

Sponsor:

University Health Network, Toronto

Code:

NCT02732860

Conditions

Colorectal Neoplasms

Colorectal Cancer

Breast Cancer

Breast Neoplasms

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures

Study Details

Brief summary:

By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options

Conditions

Colorectal Neoplasms

Colorectal Cancer

Breast Cancer

Breast Neoplasms

Ovarian Cancer

Study ID

NCT02732860

Start date

Dec, 2015

Status verified date

Apr, 2026

Completion date

Jan 4, 2027

Anticipated

Primary completion date

Jan 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Triple Negative Breast Cancer

Triple negative breast cancer patients with residual invasive disease following neoadjuvant chemotherapy (n= up to 15) or with newly diagnosed metastatic disease (n=up to 30).

After the screening procedures confirms patient eligibility:

  • Molecular Profiling will be performed on clinical sample
  • pPDX generation for in vivo drug testing
  • In vitro organoid culture generation (if sufficient fresh tissue available)
  • Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

Colorectal Cancer

Colorectal cancer patients with metastatic disease undergoing resection of liver metastases, or with lesions amenable to biopsy (n=up to 15).

After the screening procedures confirms patient eligibility:

  • Molecular Profiling will be performed on clinical sample
  • pPDX generation for in vivo drug testing
  • In vitro organoid culture generation (if sufficient fresh tissue available)
  • Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

High Grade Serous Ovarian Cancer

High grade serous ovarian cancer patients with recurrent disease with a life expectancy of at least 12 months (n=up to 15), or Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence (n=up to 15).

After the screening procedures confirms patient eligibility:

  • Molecular Profiling will be performed on clinical sample
  • pPDX generation for in vivo drug testing
  • In vitro organoid culture generation (if sufficient fresh tissue available)
  • Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

Other tumor types

Other selected tumor types at the discretion of the PI (n= up to 30)

After the screening procedures confirms patient eligibility:

  • Molecular Profiling will be performed on clinical sample
  • pPDX generation for in vivo drug testing
  • In vitro organoid culture generation (if sufficient fresh tissue available)
  • Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

Interventions

Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures

Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.

Primary outcome measure

  • Measure of drug sensitive pPDX to a panel of drugs as a predictor of clinical response in matched host [ Time Frame: up to 5 years ]
  • Rate of results reporting [ Time Frame: up to 5 years ]
  • Rate of pPDX engraftment [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Principal Investigator:

David Cescon, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • personalized patient-derived xenografts (pPDX)
  • molecular profiling
  • epigenetic analysis
  • drug sensitivity testing
  • triple negative
  • metastatic
  • serous

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-04.