A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)

Conditions

Unresectable locally-advanced or metastatic HER2+ breast cancer

Brief summary

PFS, defined as the time from randomization to investigator-assessed documented disease progression per RECIST v1.1, or death from any cause, whichever occurs first

Detailed description

OS, defined as the time from randomization to death from any cause, PFS, defined as the time from randomization to documented disease progression (as determined by BICR per RECIST v1.1), or death from any cause, whichever occurs first, Time to deterioration of HRQoL, defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30), - Central nervous system (CNS)-PFS, defined as the time from randomization to investigator-assessed disease progression in brain (RECIST v1.1), or death from any cause, whichever occurs first, Adverse events (AEs), Clinical laboratory assessments, Incidence of dose holding, dose reductions, and discontinuations of tucatinib, Incidence of dose holding and discontinuations of trastuzumab, Incidence of dose holding and discontinuations of Pertuzumab, Plasma concentrations of tucatinib

Related papers

No related papers found yet.

Interventions

DRUGTucatinib 150mg placebo tablets

DRUGPhesgo 600 mg/600 mg solution for injection

DRUGTUKYSA 150 mg film-coated tablets

DRUGTucatinib 50mg placebo tablets

DRUGTUKYSA 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS, defined as the time from randomization to investigator-assessed documented disease progression per RECIST v1.1, or death from any cause, whichever occurs first	—

Secondary

Measure	Time frame
OS, defined as the time from randomization to death from any cause, PFS, defined as the time from randomization to documented disease progression (as determined by BICR per RECIST v1.1), or death from any cause, whichever occurs first, Time to deterioration of HRQoL, defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30), - Central nervous system (CNS)-PFS, defined as the time from randomization to investigator-assessed disease progression in brain (RECIST v1.1), or death from any cause, whichever occurs first, Adverse events (AEs), Clinical laboratory assessments, Incidence of dose holding, dose reductions, and discontinuations of tucatinib, Incidence of dose holding and discontinuations of trastuzumab, Incidence of dose holding and discontinuations of Pertuzumab, Plasma concentrations of tucatinib	—

Measure

Time frame

OS, defined as the time from randomization to death from any cause, PFS, defined as the time from randomization to documented disease progression (as determined by BICR per RECIST v1.1), or death from any cause, whichever occurs first, Time to deterioration of HRQoL, defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30), - Central nervous system (CNS)-PFS, defined as the time from randomization to investigator-assessed disease progression in brain (RECIST v1.1), or death from any cause, whichever occurs first, Adverse events (AEs), Clinical laboratory assessments, Incidence of dose holding, dose reductions, and discontinuations of tucatinib, Incidence of dose holding and discontinuations of trastuzumab, Incidence of dose holding and discontinuations of Pertuzumab, Plasma concentrations of tucatinib

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Countries

Austria, Belgium, Czechia, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed