2019
Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study
Adams S, Loi S, Toppmeyer D, Cescon DW, De Laurentiis M, Nanda R, Winer EP, Mukai H, Tamura K, Armstrong A, Liu MC, Iwata H, Ryvo L, Wimberger P, Rugo HS, Tan AR, Jia L, Ding Y, Karantza V, Schmid P. Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 405-411. PMID: 30475947, DOI: 10.1093/annonc/mdy518.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPositive metastatic triple-negative breast cancerTreatment-related adverse eventsTriple-negative breast cancerDisease control rateObjective response rateFirst-line therapyProgression-free survivalAdverse eventsPD-L1Stable diseasePembrolizumab monotherapyOverall survivalCohort BControl rateBreast cancerResponse ratePD-L1 combined positive scoreCentral nervous system metastasesGrade 4 adverse eventsMedian progression-free survivalStandard first-line treatmentEnd pointGrade 3 severityManageable safety profilePembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study
Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O’Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J. Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 397-404. PMID: 30475950, DOI: 10.1093/annonc/mdy517.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerDisease control ratePD-L1Positive populationPembrolizumab monotherapyMetastatic diseaseControl rateBreast cancerTreatment-related adverse eventsEnd pointManageable safety profileObjective response ratePrimary end pointSecondary end pointsProgression-free survivalSubset of patientsDurable antitumor activityDuration of responseLine of treatmentEligible patientsMedian OSMedian PFSAdverse eventsMedian duration
2017
Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A.
Adams S, Schmid P, Rugo H, Winer E, Loirat D, Awada A, Cescon D, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O'Shaughnessy J, Loi S, Paluch-Shimon S, Card D, Zhao J, Karantza V, Cortes J. Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A. Journal Of Clinical Oncology 2017, 35: 1008-1008. DOI: 10.1200/jco.2017.35.15_suppl.1008.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTreatment-related AEsPD-L1 expressionPD-L1Manageable safetyTriple-negative breast cancerECOG PS 0Subset of ptsDisease control ratePhase 2 studyPoor prognostic factorEfficacy/safetyBest overall responseCohort A.Evaluable ptsKEYNOTE-012Median DoRMedian PFSPrior chemotherapyData cutoffPembrolizumab monotherapyDurable responsesMetastatic diseasePrior linesPS 0
2016
Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study
Tolaney SM, Nechushtan H, Ron IG, Schöffski P, Awada A, Yasenchak CA, Laird AD, O’Keeffe B, Shapiro GI, Winer EP. Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study. Breast Cancer Research And Treatment 2016, 160: 305-312. PMID: 27714541, PMCID: PMC5065609, DOI: 10.1007/s10549-016-4001-y.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalOverall survivalStable diseaseMBC patientsWeek 12Common grade 3/4 adverse eventsOverall median progression-free survivalGrade 3/4 adverse eventsMedian progression-free survivalSolid Tumors version 1.0Metastatic breast cancer patientsOral tyrosine kinase inhibitorResultsForty-five patientsDisease control rateMedian overall survivalPalmar-plantar erythrodysesthesiaResponse Evaluation CriteriaMetastatic breast carcinomaBreast cancer patientsTyrosine kinase inhibitorsCabozantinib monotherapyDiscontinuation studyPrimary endpointRespiratory failure
2011
P1-17-10: Cabozantinib (XL184) in Patients with Metastatic Breast Cancer: Results from a Phase 2 Randomized Discontinuation Trial.
Tolaney S, Nechushtan H, Berger R, Kurzrock R, Ron I, Schöffski P, Awada A, Yasenchak C, Burris H, Ramies D, Shen X, Winer E. P1-17-10: Cabozantinib (XL184) in Patients with Metastatic Breast Cancer: Results from a Phase 2 Randomized Discontinuation Trial. Cancer Research 2011, 71: p1-17-10-p1-17-10. DOI: 10.1158/0008-5472.sabcs11-p1-17-10.Peer-Reviewed Original ResearchMetastatic breast cancerObjective response rateStable diseasePartial responseBone scanBreast cancerBone metastasesNarcotic useDiscontinuation trialClinical activityWk 12Common related adverse eventsOverall disease control ratePost-baseline tumour assessmentPrior anti-VEGF therapyBone marker analysesFatigue/astheniaPrior treatment regimensPrior treatment statusDisease control rateHand-foot syndromeProgression-free survivalRelated adverse eventsAnti-VEGF therapyInvasive ductal carcinoma