Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02247037|
Recruitment Status : Recruiting
First Posted : September 23, 2014
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment|
|Triple Negative Breast Cancer||Other: Chemotherapy|
Triple negative breast cancer (TNBC) represents an aggressive, genomically heterogeneous, subtype of breast cancer with limited therapeutic options. Many patients with TNBC receive standard neoadjuvant chemotherapy (NAC) pre-operatively; response is directly correlated with long-term outcome. Patients with residual disease after NAC are at higher risk for recurrent or metastatic disease, but additional adjuvant therapies are not currently part of standard care. Personalized treatment for patients with TNBC requires an improved understanding of the genomic landscape of individual TN breast tumors, as well as improved predictive models of response to specific therapeutic agents. This pilot study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with TNBC. The tumor tissue collected (paired pre-and post NAC) will also provide insight into mechanisms of therapeutic resistance for individual patients. This study will enhance our understanding of the genomic basis for treatment response for TNBC on an individual patient basis, and lead to potential new therapeutic options for high-risk TNBC patients with post-NAC residual disease.
- To collect and bank tissue specimens from patients with operable triple negative breast cancer at: a) at time of diagnosis, prior to the start of neoadjuvant therapy and b) at time of definitive surgery, after the completion of neoadjuvant therapy.
- To collect and bank tissue specimen for patients with advanced metastatic triple negative disease prior to start of any line therapy for metastatic disease.
- To create patient-derived xenograft (PDX) mouse models utilizing specimens collected pre- and post- neoadjuvant treatment
- To determine if response of PDX tumors to cytotoxic agents in the Champions Oncology Tumor GraftTM (COTG) assay correlates with responses observed in patients.
- To perform genomic analyses of patient tumor specimens collected pre- and post neoadjuvant treatment to study mechanisms of drug resistance
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Triple Negative Breast Cancers
All women eligible for this protocol will fall into this group. These women will have histologically confirmed triple negative breast cancer and be eligible for neoadjuvant chemotherapy or have evidence of metastatic disease.
Patients are treated with neoadjuvant chemotherapy as according to the standard of care guidelines. Patients with metastatic disease are treated according to standard of care guidelines.
- Patient Tumor Response [ Time Frame: Day 1 ]Tumor response in patients will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response
- Model Tumor Response [ Time Frame: Day 1 ]Tumor response in models will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response
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): NCT02247037
|Contact: Hanna Yoko Irie, MD, PhDemail@example.com|
|Contact: Kereeti V Pisapati, MSfirstname.lastname@example.org|
|United States, New York|
|Mount Sinai Beth Israel||Withdrawn|
|New York, New York, United States, 10003|
|Mount Sinai Roosevelt||Withdrawn|
|New York, New York, United States, 10019|
|Mount Sinai St. Luke's||Withdrawn|
|New York, New York, United States, 10025|
|Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Hanna Yoko Irie, MD, PhD 212-241-3720|
|Contact: Kereeti V Pisapati, MS 212-241-2475 email@example.com|
|Principal Investigator: Hanna Yoko Irie, MD, PhD|
|Principal Investigator:||Hanna Yoko Irie, MD, PhD||Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai|
|Principal Investigator:||Elisa Port, MD||Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai|