Cortes IMpassion132 FON IFG - Future Medicine...E˜cacy of atezolizumab plus chemotherapy versus...
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Title of article IMpassion132 Phase III trial: atezolizumab and chemotherapy in early relapsing metastatic triple-negative breast cancer Article details Authors Javier Cortés, Fabrice André, Anthony Gonçalves, Sherko Kümmel, Miguel Martín, Peter Schmid, Florian Schuetz, Sandra M Swain, Valerie Easton, Erika Pollex, Regula Deurloo & Rebecca Dent Article URL www.futuremedicine.com/doi/10.2217/fon-2019-0059 Trial registration number NCT03371017 Primary objectives/rationale Primary objective Efficacy of atezolizumab plus chemotherapy versus placebo plus chemotherapy in patients with early-relapsing (<12 months) inoperable recurrent triple-negative breast cancer as measured by OS Secondary objectives Evaluate the efficacy of atezolizumab plus chemotherapy compared with placebo plus chemotherapy as assessed by 12-and 18-month OS rates, PFS, ORR, DoR and clinical benefit rate; evaluate PROs of global health status/ HRQoL associated with atezolizumab plus chemotherapy compared with chemotherapy alone, as measured by the EORTC-QLQ-C30; assess the efficacy and safety of atezolizumab plus chemotherapy according to PD-L1 status; evaluate the safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy Multinational Double-blind placebo-controlled ~100 sites globally Phase III, 2-arm Randomized patients: ~350 Two-arm randomized ? ~350 Before randomization, investigators select one of two chemotherapy regimens for each patient: a doublet of gemcitabine plus carboplatin or single-agent capecitabine Age ≥18 years Outcome measures/end points Secondary end points • 12-and 18-month OS rates • PFS • ORR • DoR • Clinical benefit rate • PROs • Pharmacokinetics • Safety Glossary DoR: Duration of objective response; EORTC-QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; HRQoL: Health-related quality of life; PROs: Patient-reported outcomes; PD-L1: Programmed death-ligand 1; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival Primary end point OS P3 Key eligibility criteria In patients previously treated with platinum, capecitabine is mandatory Treatment is continued until disease progression, unacceptable toxicity, or patient or physician decision Triple-negative breast cancer according to ASCO/CAP guidelines using a tumor sample collected ≤3 months before randomization Prior anthracycline and taxane therapy in the (neo)adjuvant setting Documented disease progression within <12 months after completing the last treatment with curative intent for early breast cancer No prior chemotherapy or targeted systemic therapy for locally advanced inoperable or metastatic recurrence ECOG performance status 0 or 1 18+ Study design and treatment including planned sample size, planned study period and study procedures 2019 Future Medicine Ltd
Cortes IMpassion132 FON IFG - Future Medicine...E˜cacy of atezolizumab plus chemotherapy versus placebo plus chemotherapy in patients with early-relapsing (
