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A Study of the Expression and Frequency of Tissue Biomarker Mutations in Breast Cancer that is Resistant or Refractory to Treatment with Trastuzumab and/or Pertuzumab

Overview

Información sobre este estudio

The purpose of this study is to measure the expression and frequency of the tumor tissue biomarkers (the genetics) of breast cancer, specifically the decreased presence and amount of a specific protein (Human epidermal growth factor receptor-2 [HER2]), how often genetic mutations occur, and why the cancer might or might not respond to monoclonal antibody therapy, such as trastuzumab emtansine (T-DM1) and/or pertuzumab.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Study closed to enrollment

Inclusion Criteria

  • Able to understand and willing to sign the informed consent form
  • Capable of providing written authorization for use and disclosure of protected health information per requirements of 45 Code of Federal Regulations (CFR) 164.508 (Health Insurance Portability and Accountability Act [HIPPA]), if applicable, before performance of any study-specific procedures or tests
  • ≥ 18 years old
  • Willing and able to undergo core biopsy or surgical resection/excision procedure on accessible tumor
  • Histologically confirmed diagnosis of HER2-positive metastatic breast cancer or cancer resistant to neoadjuvant therapy as determined by the Investigator as either
    • Presence of a tumor that demonstrated radiographic progression, with > 20% increase in longest diameter or newly emerged, during or within 2 months of stopping T-DM1 and/or pertuzumab-based therapy
    • Presence of a primary breast tumor that demonstrated < 50% regression in longest diameter during trastuzumab and pertuzumab-based neoadjuvant chemotherapy

Exclusion Criteria

  • Tumor biopsy or resection presents an unusual safety risk
  • Progressing tumor is in an anatomic location that is unreasonable to biopsy/excise, as determined by the Investigator
  • Risks associated with biopsy/resection will be greater than benefits received, as determined by the Investigator

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20301163

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