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

NCT02247037 | Completed DMC

• 1 other identifier: GCO 14-0686
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer; Patient Derived Xenograft; Neoadjuvant Chemotherapy; Therapeutic Resistance

Outcome Measures

Primary Outcomes (1)

• Patient Tumor Response

  Tumor response in patients will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response

  Day 1

Secondary Outcomes (1)

• Model Tumor Response

  Day 1

Study Arms (1)

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

Interventions

Chemotherapy OTHER

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.

Triple Negative Breast Cancers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Champions Oncology: collaborator

Study Sites (1)

Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Core Biopsy Specimen, Surgical Specimen

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: July 1, 2014
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)