2023
Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial.
Ligibel J, Ballman K, McCall L, Goodwin P, Weiss A, Delahanty L, Alfano C, Crane T, Neuhouser M, Spears P, Hershman D, Paskett E, Hopkins J, Bernstein V, Stearns V, White J, Wadden T, Winer E, Partridge A, Carey L. Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial. Journal Of Clinical Oncology 2023, 41: 12001-12001. DOI: 10.1200/jco.2023.41.16_suppl.12001.Peer-Reviewed Original ResearchWeight loss interventionBody mass indexEarly breast cancerWeight loss trialBreast cancerHealth educationTumor factorsWeight lossLoss trialHER2-negative breast cancerInvasive disease-free survivalTelephone-based health coachingBreast cancer ptsBaseline body weightDisease-free survivalMeaningful weight lossMonths of diagnosisPoor prognostic factorTime of diagnosisBreast cancer patientsSignificant weight lossMultivariable regression modelsRace/ethnicityCancer ptsEligible pts
2019
A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Barroso-Sousa R, Krop I, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson E, Winer E, Mittendorf E, Schoenfeld J, Tolaney S. A phase II study of pembrolizumab in combination with palliative radiotherapy (RT) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1047-1047. DOI: 10.1200/jco.2019.37.15_suppl.1047.Peer-Reviewed Original ResearchMetastatic breast cancerNeutrophil/lymphocyte ratioObjective response rateProgression-free survivalTumor-infiltrating lymphocytesPalliative radiotherapyAdverse eventsHormone receptor-positive metastatic breast cancerPhase II single-arm studyMedian progression-free survivalCause adverse eventsDistant tumor responsesECOG PS 1Prior cytotoxic therapyImmune checkpoint inhibitorsPD-L1 expressionPD-L1 statusPhase II studySingle-arm studyTotal RT doseUnexpected adverse eventsECOG PSEligible ptsRECIST v1.1Measurable lesionsIMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Henschel V, Molinero L, Chui S, Husain A, Winer E, Loi S, Emens L. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1003-1003. DOI: 10.1200/jco.2019.37.15_suppl.1003.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerOverall survivalPD-L1OS analysisTriple-negative breast cancerECOG PS 0Median overall survivalPrimary PFS analysisPD-L1 testingPhase III studyCo-primary endpointsEligible ptsOS benefitData cutoffIII studyNab-paclitaxelPS 0AtezoBreast cancerPFS analysisPlaceboNP armTumor tissueSafety updateOS data
2013
TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets).
Anders C, Deal A, Abramson V, Liu M, Storniolo A, Carpenter J, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin N, Marcom P, Van Poznak C, Stearns V, Melisko M, Smith J, Karginova O, Winer E, Perou C, Wolff A, Carey L. TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2013, 31: 515-515. DOI: 10.1200/jco.2013.31.15_suppl.515.Peer-Reviewed Original ResearchQuality of lifeBlood-brain barrierResponse rateCommon grade 3/4 adverse eventsCentral nervous system metastasesGrade 3/4 adverse eventsClinical benefit rateNervous system metastasesPhase II studyTumor response rateKaplan-Meier methodWhole brain RTHalf of womenBetter response rateSmall molecule anti-cancer agentTopoisomerase I inhibitorAdvanced TNBCCorrelative endpointsEligible ptsGermline BRCA1/2Measurable lesionsMedian TTPRadiation-naïveAnti-cancer agentsPrimary endpoint
2011
OT3-02-04: TBCRC 012: ABCDE, a Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise after Preoperative Chemotherapy for Breast Cancer.
Mayer E, Ligibel J, Burstein H, Peppercorn J, Miller K, Carey L, Dickler M, Mayer I, Forero A, Eng-Wong J, Pletcher P, Ryabin N, Gelman R, Wolff A, Winer E. OT3-02-04: TBCRC 012: ABCDE, a Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise after Preoperative Chemotherapy for Breast Cancer. Cancer Research 2011, 71: ot3-02-04-ot3-02-04. DOI: 10.1158/0008-5472.sabcs11-ot3-02-04.Peer-Reviewed Original ResearchPreoperative chemotherapyBreast cancerLifestyle interventionPhase II Randomized StudyAcceptable organ functionResidual invasive diseaseAdjuvant combination chemotherapyTaxane-based chemotherapyRecurrence-free survivalResidual breast cancerRisk of recurrenceFuture clinical trialsStructured exercise programImpact of exerciseAnti-angiogenic agentsUnmet medical needContribution of exerciseQuality of lifeYear BAdjuvant bevacizumabDFCI 05Eligible ptsLast surgeryNeoadjuvant chemotherapyPrimary endpoint
2007
EGF105084, a phase II study of lapatinib for brain metastases in patients (pts) with HER2+ breast cancer following trastuzumab (H) based systemic therapy and cranial radiotherapy (RT)
Lin N, Dieras V, Paul D, Lossignol D, Christodoulou C, Laessig D, Roché H, Zembryki D, Oliva C, Winer E. EGF105084, a phase II study of lapatinib for brain metastases in patients (pts) with HER2+ breast cancer following trastuzumab (H) based systemic therapy and cranial radiotherapy (RT). Journal Of Clinical Oncology 2007, 25: 1012-1012. DOI: 10.1200/jco.2007.25.18_suppl.1012.Peer-Reviewed Original ResearchNeurological signs/symptomsCNS diseaseCranial radiotherapyBreast cancerBrain metastasesSystemic therapyInitial phase II trialDose of steroidsECOG PS 0Extra-CNS diseaseIndependent radiology reviewProgressive brain metastasesPhase II studyPhase II trialLarge multicenter trialsSigns/symptomsCNS disease progressionAnalysis of efficacyPreliminary dataEligible ptsH therapyPo bidRefractory settingAccrual goalII trial