2021
Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations
Xu J, Keenan TE, Overmoyer B, Tung NM, Gelman RS, Habin K, Garber JE, Ellisen LW, Winer EP, Goss PE, Yeap BY, Chabner BA, Isakoff SJ. Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations. Breast Cancer Research And Treatment 2021, 189: 641-651. PMID: 34417675, DOI: 10.1007/s10549-021-06292-7.Peer-Reviewed Original ResearchConceptsObjective response rateClinical benefit rateProgression-free survivalMedian progression-free survivalMetastatic breast cancer patientsPhase II trialMetastatic breast cancerBreast cancer patientsBRCA1/2 carriersBreast cancerExpansion cohortII trialPrimary endpointPrimary cohortCancer patientsBenefit rateBRCA1/2 mutationsDay 1Longer median progression-free survivalSingle-arm phase II trialCommon grade 3Doses of veliparibPlatinum-naïve patientsPrior platinum therapyBRCA mutation carriersPembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial
Winer EP, Lipatov O, Im SA, Goncalves A, Muñoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J, investigators K. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. The Lancet Oncology 2021, 22: 499-511. PMID: 33676601, DOI: 10.1016/s1470-2045(20)30754-3.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerCombined positive scoreMedian overall survivalPD-L1 combined positive scoreTreatment-related adverse eventsPhase 3 trialChemotherapy groupOverall survivalPembrolizumab groupBreast cancerAdverse eventsPrimary endpointMetastatic diseaseEastern Cooperative Oncology Group performance statusPD-L1 tumor statusCommon grade 3Durable antitumour activityInvestigator-choice chemotherapyPrevious systemic treatmentSerious adverse eventsThird-line treatmentSubpopulation of patientsTreatment of patientsSingle-drug chemotherapyPalbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study
Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. The Lancet Oncology 2021, 22: 212-222. PMID: 33460574, DOI: 10.1016/s1470-2045(20)30642-2.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalAdjuvant endocrine therapyDisease-free survivalInvasive disease-free survival eventsDisease-free survival eventsEndocrine therapySecond interim analysisBreast cancerInterim analysisAdverse eventsEastern Cooperative Oncology Group performance scoreSecond pre-planned interim analysisHER2-negative breast cancerEarly-stage breast cancerSurvival eventsIndependent data monitoring committeePre-planned interim analysisCommon grade 3Treatment-related deathsSerious adverse eventsProgression-free survivalEarly breast cancerMetastatic breast cancerInteractive response technologyGroup performance score
2016
Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. New England Journal Of Medicine 2016, 375: 1738-1748. PMID: 27717303, DOI: 10.1056/nejmoa1609709.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease-Free SurvivalDouble-Blind MethodDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLetrozoleMiddle AgedNeoplasm StagingNitrilesPurinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTriazolesConceptsAdvanced breast cancerProgression-free survivalHuman epidermal growth factor receptor 2Overall response rateRibociclib groupBreast cancerPlacebo groupAdverse eventsInvestigator-assessed progression-free survivalHER2-negative advanced breast cancerResponse rateProgression-free survival ratesEnd pointEpidermal growth factor receptor 2Hormone receptorsCDK4/6 inhibitor ribociclibCommon grade 3Initial systemic treatmentPrevious systemic therapyPrimary end pointSecondary end pointsFirst-line treatmentPhase 3 trialRate of discontinuationGrowth factor receptor 2