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Spots Global Cancer Trial Database for Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer

Official Title: Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer

Study ID: NCT02247037

Interventions

Chemotherapy

Study Description

Brief Summary: This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with triple negative breast cancer. The collection of patient tumor tissue will also provide insight into the mechanisms of therapeutic resistance for those individuals. Ultimately, this study will enhance our understanding of the genomic basis for treatment response for triple negative cancer on an individual basis, while having the potential to suggest new therapeutic options for high-risk triple negative breast cancer patients with residual disease post neoadjuvant.

Detailed Description: 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. Objectives: 1. 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. 2. To collect and bank tissue specimen for patients with advanced metastatic triple negative disease prior to start of any line therapy for metastatic disease. 3. To create patient-derived xenograft (PDX) mouse models utilizing specimens collected pre- and post- neoadjuvant treatment 4. To determine if response of PDX tumors to cytotoxic agents in the Champions Oncology Tumor GraftTM (COTG) assay correlates with responses observed in patients. 5. To perform genomic analyses of patient tumor specimens collected pre- and post neoadjuvant treatment to study mechanisms of drug resistance

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai, New York, New York, United States

Contact Details

Name: Hanna Yoko Irie, MD, PhD

Affiliation: Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai

Role: PRINCIPAL_INVESTIGATOR

Name: Elisa Port, MD

Affiliation: Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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