2022
Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2017
215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Demichele A, Pfeiler G, Barry W, Metzger O, Rastogi P, Symmans F, Burstein H, Miller K, Loibl S, Schmatloch S, Goulioti T, Zardavas D, Fesl C, Koehler M, Bartlett C, Huang X, Piccart M, Winer E, Gnant M. 215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2017, 28: v66. DOI: 10.1093/annonc/mdx362.064.Peer-Reviewed Original Research
2016
Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527
Freedman RA, Foster JC, Seisler DK, Lafky JM, Muss HB, Cohen HJ, Mandelblatt J, Winer EP, Hudis CA, Partridge AH, Carey LA, Cirrincione C, Moreno-Aspitia A, Kimmick G, Jatoi A, Hurria A. Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal Of Clinical Oncology 2016, 35: 421-431. PMID: 27992272, PMCID: PMC5455700, DOI: 10.1200/jco.2016.69.4182.Peer-Reviewed Original ResearchConceptsOlder patientsMetastatic trialsAdjuvant trialsBreast cancerHormone receptor-negative tumorsBreast cancer treatment trialConclusion Older patientsSystemic therapy trialsReceptor-negative tumorsBreast cancer trialsCancer treatment trialsYears of ageAccrual challengesNeoadjuvant trialsAdjuvant studiesPatient ageTherapy cessationLymph nodesTherapeutic trialsTreatment cessationTumor sizeDisease characteristicsPatient populationTreatment trialsCancer trials
2015
Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)
Ruddy KJ, Guo H, Barry W, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Hudis C, Krop IE, Burstein HJ, Winer EP, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial). Breast Cancer Research And Treatment 2015, 151: 589-596. PMID: 25981899, PMCID: PMC5057177, DOI: 10.1007/s10549-015-3426-z.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaChemotherapy initiationMenopausal symptomsBreast cancerAdjuvant breast cancer therapyEarly-stage breast cancerNode-negative HER2Weeks of paclitaxelStage breast cancerLast menstrual periodBreast cancer therapyAdjuvant paclitaxelAmenorrhea ratesAPT trialEligible patientsEvaluable populationPremenopausal womenAdjuvant studiesTrastuzumab monotherapyMedian timeMenstrual periodCancer regimensAmenorrheaTrastuzumabMonths