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HER2CLIMB: Phase II randomized, double-blinded, controlled study of tucatinib vs placebo in combination With capecitabine and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast carcinoma

Description

The purpose of this study is to test study treatments that combine an investigational drug (tucatinib, which is also known as ONT-380) (the “study drug”) with two approved drugs (capecitabine and trastuzumab) in participants with advanced breast cancer to find out what effects, good or bad, it may have on the participants and their disease.

Status

Accepting new patients

Primary Study Objective(s)

The primary outcome measure of this study is progression-free survival per RECIST 1.1 based on independent central review.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have histologically confirmed HER2-positive breast carcinoma
  • Have received previous treatment with a taxane, trastuzumab, pertuzumab and T-DM1
  • Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or been identified as intolerant of last systemic therapy
  • Have measurable or non-measurable disease assessable by RECIST 1.1
  • Are at least 18 years of age at time of consent
  • Have Eastern Cooperative Oncology Group Performance Status 0 or 1
  • Have central nervous system inclusion, based on screening brain magnetic resonance imaging (MRI). Such patients must have one of the following:
    • No evidence of brain metastases
    • Untreated brain metastases not needing immediate local therapy
    • Previously treated brain metastases
      • Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local central nervous system therapy.
      • Relevant records of any central nervous system treatment must be available to allow for classification of target and non-target lesions.
      • Patients treated with central nervous system local therapy for newly identified lesions found on initial MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
        • Time since WBRT is > 21 days prior to first dose of treatment, time since SRS is > seven days prior to first dose of treatment, or time since surgical resection is > 28 days.
        • Other sites of evaluable disease are present.

Excluding patients who:

  • Have previously been treated with:
    • Lapatinib within 12 months of starting study treatment or
    • neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor or HER2 tyrosine kinase inhibitor at any time previously
  • Have previously been treated with capecitabine for metastatic disease. Note: Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.

Learn more about breast cancer

     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Cynthia Lynch

Sramila Aithal

John E. McKnight