pertuzumab plus chemotherapy for platinumresistant ovarian cancer safety runin results of the penelope trial objective in platinumresistant ovarian cancer adding pertuzumab to gemcitabine improved progressionfree survival in the subgroup with low tumor her3 messenger rna expression the 2part penelope trial nct01684878 is prospectively investigating pertuzumab plus chemotherapy in this populationpatients and methods part 1 evaluated pertuzumab plus either topotecan or paclitaxel patients with platinumrefractory or platinumresistant recurrent ovarian primary peritoneal or fallopian tube cancer and low her3 messenger rna expression concentration ratio 281 by central quantitative reverse transcriptasepolymerase chain reaction testing on cobas z480 received intravenous pertuzumab 840 mg loading dose then 420 mg every 3 weeks with the investigators choice of topotecan 125 mgm days 15 every 3 weeks or weekly paclitaxel 80 mgm until disease progression or unacceptable toxicity the primary objective was to assess safety and tolerabilityresults fifty patients were treated in part 1 22 topotecan 28 paclitaxel in both cohorts disease progression was the most common primary reason for discontinuing pertuzumab and the most common allgrade adverse events aes were fatigueasthenia anemia and diarrhea the most common grade 3 aes were anemia 36 neutropenia 27 and fatigueasthenia 18 for topotecan and peripheral sensory neuropathy 14 and anemia 11 for paclitaxel two patients receiving paclitaxelpertuzumab died from aes abdominal infection unexplained death median progressionfree survival was 41 months 95 confidence interval 1961 with topotecanpertuzumab and 42 months 95 confidence interval 3560 with paclitaxelpertuzumabconclusions based on part 1 tolerability the independent data monitoring committee had no objection to penelope proceeding to part 2 a doubleblind randomized comparison of chemotherapy topotecan paclitaxel or gemcitabine plus pertuzumab or placebo