2017
Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial.
Spring L, Goel S, Juric D, Isakoff S, Haddad S, Habin K, Krop I, Moy B, Tolaney S, Bardia A. Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial. Journal Of Clinical Oncology 2017, 35: tps1106-tps1106. DOI: 10.1200/jco.2017.35.15_suppl.tps1106.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerHER2-positive breast cancerObjective response rateProgression-free survivalMetastatic breast cancerT-DM1Breast cancerTrastuzumab emtansinePhase 1b clinical trialDose-expansion cohortsMTD/RP2DPhase 2 doseDose-escalation designPre-clinical modelsInhibition of CDK4/6Cyclin-dependent kinase 4Multiple effective therapiesHER receptor familyEligible patientsRECIST 1.1Most patientsPatient ageDependent kinase 4Escalation design
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