2018
Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer
Kuang Y, Siddiqui B, Hu J, Pun M, Cornwell M, Buchwalter G, Hughes ME, Wagle N, Kirschmeier P, Jänne PA, Paweletz CP, Lin NU, Krop IE, Barry WT, Winer EP, Brown M, Jeselsohn R. Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer. Npj Breast Cancer 2018, 4: 22. PMID: 30083595, PMCID: PMC6072793, DOI: 10.1038/s41523-018-0075-5.Peer-Reviewed Original ResearchMetastatic breast cancerESR1 mutationsBreast cancerMetastatic settingClinicopathological featuresPIK3CA mutationsAromatase inhibitorsER-positive metastatic breast cancerDetailed clinical dataSpecific systemic treatmentMetastatic treatmentDistant recurrenceMetastatic diseaseSystemic treatmentPrimary diseaseEndocrine resistanceCDK4/6 inhibitorsPathological featuresFulvestrant treatmentClinical dataPrior treatmentSignificant associationPatientsCancerPrevalenceThe tumor-immune microenvironment (TME) in HR+/HER2- metastatic breast cancer (mBC): Relationship to non-metastatic (met) tumors and prior treatment (tx) received.
Waks A, Tolaney S, Schnitt S, Dillon D, Gjini E, Abdelrahman S, Marino-Enriquez A, Helvie K, Marini L, Cohen O, Kim D, Wander S, Stover D, Rodig S, Krop I, Winer E, Lin N, Wagle N. The tumor-immune microenvironment (TME) in HR+/HER2- metastatic breast cancer (mBC): Relationship to non-metastatic (met) tumors and prior treatment (tx) received. Journal Of Clinical Oncology 2018, 36: 1054-1054. DOI: 10.1200/jco.2018.36.15_suppl.1054.Peer-Reviewed Original Research
2012
LBA12 Results from Emilia, A Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine (X) and Lapatinib (L) in Her2-Positive Locally Advanced or Metastatic Breast Cancer (MBC)
Verma S, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Diéras V, Guardino E, Fang L, Lu M, Olsen S, Blackwell K. LBA12 Results from Emilia, A Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine (X) and Lapatinib (L) in Her2-Positive Locally Advanced or Metastatic Breast Cancer (MBC). Annals Of Oncology 2012, 23: ixe5-ixe6. DOI: 10.1016/s0923-7534(20)34362-3.Peer-Reviewed Original ResearchProgression-free survivalGenentech/RocheMetastatic breast cancerClinical benefit rateSecondary end pointsT-DM1Overall survivalEnd pointObjective responseTreatment failureBenefit ratePrior treatmentKey secondary end pointInterim overall survivalObjective response ratePrimary end pointSubgroups of ptsHormone receptor statusStudy end pointPhase 3 studyDuration of responsePotential new therapiesFinal PFS analysisCardiac AEsMBC therapy
2011
PD09-04: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of the PI3-Kinase Inhibitor GDC-0941 in Combination with Paclitaxel and Bevacizumab in Patients with Locally Recurrent or Metastatic Breast Cancer.
Schöffski P, De Benedictis E, Gendreau S, Gianni L, Krop I, Levy G, Ware J, Wildiers H, Winer E. PD09-04: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of the PI3-Kinase Inhibitor GDC-0941 in Combination with Paclitaxel and Bevacizumab in Patients with Locally Recurrent or Metastatic Breast Cancer. Cancer Research 2011, 71: pd09-04-pd09-04. DOI: 10.1158/0008-5472.sabcs11-pd09-04.Peer-Reviewed Original ResearchMetastatic BCDay 1Prior treatmentPhase Ib studyDose-escalation studySubclavian vein thrombosisMetastatic breast cancerSingle-agent activityDose-escalation designCycle 1Breast cancer cell linesClass I PI3K isoformsAnti-cancer therapyPI3K pathwayPhosphorylation of AktAdditional DLTsCancer cell linesDrug holidayOpen labelVein thrombosisEscalation designPI3K isoformsLocally RecurrentChemotherapy treatmentCohort 2