2021
Trial in progress: A phase 1b/2 study of the PARP inhibitor niraparib in combination with trastuzumab in patients with metastatic HER2+ breast cancer (TBCRC 050).
Stringer-Reasor E, Li Y, Witherspoon F, Specht J, Del Santo Anampa Mesias J, Nanda R, Dees E, Wolff A, Krop I, Lin N, Rimawi M, Yang E. Trial in progress: A phase 1b/2 study of the PARP inhibitor niraparib in combination with trastuzumab in patients with metastatic HER2+ breast cancer (TBCRC 050). Journal Of Clinical Oncology 2021, 39: tps1098-tps1098. DOI: 10.1200/jco.2021.39.15_suppl.tps1098.Peer-Reviewed Original ResearchHuman epidermal growth factor receptor 2Metastatic human epidermal growth factor receptor 2Dose-limiting toxicityBreast cancerResponse rateBC cellsEpidermal growth factor receptor 2Single-arm clinical trialECOG PS 0Efficacy of niraparibObjective response ratePhase 1b/2 studyGrowth factor receptor 2Arm clinical trialPARP inhibitor niraparibFactor receptor 2Poly (ADP-ribose) polymerase (PARP) inhibitorsNF-kB signalingMeasurable diseasePhase 1b/2Accrual goalEligible patientsPS 0Clinical benefitCNS disease
2013
Phase II study of ruxolitinib in patients with pStat3+ breast cancer.
Lin N, Gelman R, Brock J, Bardia A, Mayer E, Overmoyer B, Wang V, Iannone M, Krop I, Polyak K, Winer E. Phase II study of ruxolitinib in patients with pStat3+ breast cancer. Journal Of Clinical Oncology 2013, 31: tps1134-tps1134. DOI: 10.1200/jco.2013.31.15_suppl.tps1134.Peer-Reviewed Original ResearchBreast cancerObjective responseCohort BCohort AOpen-label phase 2 trialIL-6/JAK2/STAT3Tumor tissueM.D. Anderson Symptom InventoryTriple-negative breast cancerAdequate organ functionBaseline tumor biopsiesECOG PS 0High-risk myelofibrosisPhase II studyEORTC QLQ CPhase 2 trialInflammatory breast cancerArchival tumor tissueWk 4JAK2/STAT3Further studiesAccessible diseaseMeasurable diseasePrior therapyPrimary endpoint
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