A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC)
Yardley DA, Young RR, Adelson KB, Silber AL, Najera JE, Daniel DB, Peacock N, Finney L, Hoekstra SJ, Shastry M, Hainsworth JD, Burris HA. A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC). Clinical Breast Cancer 2021, 22: 269-278. PMID: 34824002, DOI: 10.1016/j.clbc.2021.10.011.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerCohort 2Cohort 1Breast cancerAndrogen biosynthesisAmylase/lipaseLimited clinical activityPrior chemotherapy regimenPrior chemotherapy regimensMedian treatment durationNausea/vomitingChemotherapy regimenChemotherapy regimensPrimary endpointObjective responseOverall survivalFemale patientsAndrogen receptorClinical activityGrade 3Targetable pathwaysPatientsTherapeutic targetAR modulationTreatment durationNeoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer
Foldi J, Silber A, Reisenbichler E, Singh K, Fischbach N, Persico J, Adelson K, Katoch A, Horowitz N, Lannin D, Chagpar A, Park T, Marczyk M, Frederick C, Burrello T, Ibrahim E, Qing T, Bai Y, Blenman K, Rimm DL, Pusztai L. Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer. Npj Breast Cancer 2021, 7: 9. PMID: 33558513, PMCID: PMC7870853, DOI: 10.1038/s41523-021-00219-7.Peer-Reviewed Original ResearchStromal tumor-infiltrating lymphocytesWeekly nab-paclitaxelTriple-negative breast cancerPD-L1Nab-paclitaxelAdverse eventsBreast cancerGrade 3/4 treatment-related adverse eventsPhase I/II trialGrade 3/4 adverse eventsTreatment-related adverse eventsDoxorubicin/cyclophosphamidePhase II studyGuillain-Barre syndromeMononuclear inflammatory cellsPathologic complete responseTumor-infiltrating lymphocytesTumor cell stainingEvaluable patientsNeoadjuvant durvalumabSP263 antibodyII trialNeoadjuvant chemotherapyNeoadjuvant therapyPrimary endpoint