Last updated on June 2020

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Cervical Cancer | Metastatic Breast Cancer | HER2-Negative Metastatic Breast Cancer | Hormone Receptor-Positive
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Women and men who are 18 years old at signing of informed consent
  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Provide written informed consent to participate in the study and for circulating tumor DNA screening
  • Must be able to provide blood sample(s) for HER2 mutation testing
  • Participants with imaging or histologically confirmed, HR-positive, HER2-negative MBC who are presently receiving or have received CDK4/6 inhibitor as a prior therapy in any setting, or participants with imaging or histologically confirmed metastatic cervical cancer
  • At least one measurable lesion, as defined by RECIST v1.1

Exclusion Criteria:

  • Participants with breast cancer with known HER2-positive or HER2-amplified tumors
  • Participants with breast cancer with HR-negative tumors
  • Participants who have received HER2-directed TKI
  • Participants with previously documented somatic KRAS activating mutation

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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