Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host (REFLECT)

  • End date
    Nov 30, 2023
  • participants needed
  • sponsor
    University Health Network, Toronto
Updated on 30 April 2022
systemic therapy
breast cancer
residual tumor
liver metastasis
cancer treatment
cancer chemotherapy
recurrent disease
triple negative breast cancer
stage iv colorectal cancer
cancer of the ovary


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


Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.

Condition Colorectal Neoplasms, Colorectal Cancer, Breast Cancer, Breast Neoplasms, Ovarian Cancer, Ovarian Neoplasm
Treatment Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures
Clinical Study IdentifierNCT02732860
SponsorUniversity Health Network, Toronto
Last Modified on30 April 2022


Yes No Not Sure

Inclusion Criteria

Age > 18 years
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
(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
(III) Histologically-confirmed advanced High Grade Serous Ovarian Cancer, either
Stage III or IV with residual disease following neoadjuvant chemotherapy, or at
Recurrent disease with a life expectancy of at least 12 months or
risk of high recurrence
(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
Disease amenable to biopsy or surgery for tissue procurement
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Willingness and ability of patient to provide signed voluntary informed consent

Exclusion Criteria

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note