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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 : November 6, 2019
Sponsor:
Collaborator:
Champions Oncology
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment
Triple Negative Breast Cancer Other: Chemotherapy

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

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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.
Other: Chemotherapy
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.




Primary Outcome Measures :
  1. Patient Tumor Response [ Time Frame: Day 1 ]
    Tumor response in patients will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response


Secondary Outcome Measures :
  1. 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
Core Biopsy Specimen, Surgical Specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Triple Negative Breast Cancer that are eligible for neoadjuvant chemotherapy or have evidence of metastatic disease will be pursued for this protocol.
Criteria

Inclusion Criteria:

  • a histological diagnosis of invasive triple negative breast cancer determined by standard immunohistochemical analysis.
  • must be candidates for neoadjuvant chemotherapy according to standard of care guidelines or have evidence of metastatic disease.
  • must agree to a biopsy for research purposes at time of diagnosis and to undergo surgery at the hospitals of the Mount Sinai Health System.

Patients with the following MAY be eligible:

- a histological diagnosis of ER and/or PR positive breast cancer with an overall receptor expression ≤ 30% breast cancer determined by standard immunohistochemical analysis

Exclusion Criteria:

  • concurrent disease or condition that would make the patient inappropriate for study participation,
  • any serious medical or psychiatric disorder that would interfere with the subject's safety, or inability to provide informed consent.
  • vulnerable populations will not be included.

Information from the National Library of Medicine

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


Contacts
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Contact: Hanna Yoko Irie, MD, PhD 212-241-3720 hanna.irie@mssm.edu
Contact: Kereeti V Pisapati, MS 212-241-2475 kereeti.pisapati@mountsinai.org

Locations
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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    kereeti.pisapati@mountsinai.org   
Principal Investigator: Hanna Yoko Irie, MD, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Champions Oncology
Investigators
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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

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02247037     History of Changes
Other Study ID Numbers: GCO 14-0686
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Keywords provided by Icahn School of Medicine at Mount Sinai:
Triple Negative Breast Cancer
Patient Derived Xenograft
Neoadjuvant Chemotherapy
Therapeutic Resistance
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases