2014
Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer
Tolaney S, Burris H, Gartner E, Mayer IA, Saura C, Maurer M, Ciruelos E, Garcia AA, Campana F, Wu B, Xu Y, Jiang J, Winer E, Krop I. Phase I/II study of pilaralisib (SAR245408) in combination with trastuzumab or trastuzumab plus paclitaxel in trastuzumab-refractory HER2-positive metastatic breast cancer. Breast Cancer Research And Treatment 2014, 149: 151-161. PMID: 25537644, DOI: 10.1007/s10549-014-3248-4.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerAdverse eventsBreast cancerArm 2Arm 1Phase I/II dose-escalation studyMetastatic HER2-positive breast cancerPhase I/II studyTreatment-related adverse eventsHER2-positive breast cancerTreatment-related gradeAcceptable safety profileDose-escalation studyDose-limiting toxicityDose-escalation designPan-class IEvaluable patientsPaclitaxel armPrior taxanePrior trastuzumabErythematous rashII studyPartial responsePeripheral neuropathy
2011
P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen.
Tolaney S, Burris H, Gartner E, Mayer I, Saura C, Maurer M, DeCillis A, Ruiz-Soto R, Lager J, Winer E, Krop I. P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen. Cancer Research 2011, 71: p1-17-02-p1-17-02. DOI: 10.1158/0008-5472.sabcs11-p1-17-02.Peer-Reviewed Original ResearchPhase 1/2 studyMetastatic breast cancerOverall response rateArm 1Arm 2Epigastric painMulticenter phase 1/2 studyPan-PI3K inhibitorECOG PS 0Preliminary PK dataDose-escalation designAge 55 yrPhase 2 portionDifferent dose levelsPhase 1PI3K pathwayDisease refractoryFemale ptsMost HER2Recurrent HER2MBC patientsMetastatic diseaseAdverse eventsPeripheral neuropathyPS 0
2009
Assays of circulating tumor cells and outcome in the triple-negative breast cancer trial TBCRC001.
Rugo H, Carey L, Mayer E, Marcom P, Liu M, Ma C, Storniolo A, Forero A, Esteva F, Wolff A, Hobday T, Ferraro M, Davidson N, Winer E, Moore D, Scott J, Park J. Assays of circulating tumor cells and outcome in the triple-negative breast cancer trial TBCRC001. Cancer Research 2009, 69: 6048. DOI: 10.1158/0008-5472.sabcs-6048.Peer-Reviewed Original ResearchBasal-like breast cancerArm 1Study treatmentCTC levelsTumor cellsPhase II studyPhase II trialTime pointsBreast cancer trialsMarkers of activityRank correlation coefficientCc bloodMetastatic BrCaShorter TSTPrimary endpointII studyII trialObjective responseFirst infusionCancer trialsEfficacy dataArm 2Breast cancerCTC measurementCTC enumeration
2006
Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules
Burstein HJ, Overmoyer B, Gelman R, Silverman P, Savoie J, Clarke K, Dumadag L, Younger J, Ivy P, Winer EP. Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules. Investigational New Drugs 2006, 25: 161-164. PMID: 16969707, DOI: 10.1007/s10637-006-9007-6.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerDifferent treatment schedulesBreast cancerTreatment scheduleAdjuvant chemotherapyArm 2Arm 1Response rateAnthracycline-based adjuvant chemotherapyRefractory advanced breast cancerRandomized phase II trialPrior chemotherapy regimensRefractory breast cancerModest clinical activityPhase II trialPrimary study endpointMetastatic breast cancerCentral venous accessAnemia 5Eligible patientsMeasurable diseaseNausea/Prior chemotherapyStable diseaseChemotherapy regimens