Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04608357|
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : October 14, 2021
|Condition or disease||Intervention/treatment|
|Breast Cancer Breast Neoplasms Metastatic Breast Cancer Cancer, Breast||Diagnostic Test: Needle Core Biopsies|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||25 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients|
|Actual Study Start Date :||July 21, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
- Diagnostic Test: Needle Core Biopsies
Not an interventional study
- 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
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608357
|Contact: Katarzyna J Jerzak, MD MSc FRCPC||416-480-6100 ext firstname.lastname@example.org|
|Contact: Hon S Leong||416-480-6100 ext email@example.com|
|Principal Investigator:||Katarzyna J Jerzak, MD MSc FRCPC||Sunnybrook Health Sciences Centre|