2018
A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer
Schöffski P, Cresta S, Mayer IA, Wildiers H, Damian S, Gendreau S, Rooney I, Morrissey KM, Spoerke JM, Ng VW, Singel SM, Winer E. A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer. Breast Cancer Research 2018, 20: 109. PMID: 30185228, PMCID: PMC6125885, DOI: 10.1186/s13058-018-1015-x.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityPhase Ib studyMetastatic breast cancerAdverse eventsBreast cancerIb studyResultsSixty-nine patientsAntitumor activityManageable safety profileAdvanced breast cancerSerious adverse eventsPreliminary antitumor activityDrug-drug interactionsEvaluation of safetySecondary endpointsPartial responseComplete responseDose escalationRandomized studySafety profilePatientsBevacizumabTrastuzumabPictilisibLetrozoleIdentification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study
Li D, McCall LM, Hahn OM, Hudis CA, Cohen HJ, Muss HB, Jatoi A, Lafky JM, Ballman KV, Winer EP, Tripathy D, Schneider B, Barry W, Dickler MN, Hurria A. Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Research And Treatment 2018, 171: 325-334. PMID: 29789969, PMCID: PMC6076849, DOI: 10.1007/s10549-018-4828-5.Peer-Reviewed Original ResearchConceptsHormone receptor-positive advanced breast cancerAdvanced breast cancerIncidence of gradeAdverse eventsBreast cancerPhysical functionProgression-free survival benefitMultivariable logistic regression modelAddition of bevacizumabPhase III trialsPhysical function measuresAdverse event dataFunctional Assessment MeasureIncidence of toxicityFlight of stairsLogistic regression modelsHemorrhagic eventsIII trialsSurvival benefitMedian ageThrombosis eventsRisk factorsUnivariate analysisAssessment measuresBevacizumab
2016
Identifying risk factors for toxicity in patients (Pts) with hormone-receptor positive (HR+) advanced breast cancer treated with bevacizumab plus letrozole: A CALGB 40503 (Alliance) correlative study.
Li D, Dickler M, McCall L, Hahn O, Hudis C, Cohen H, Muss H, Ballman K, Winer E, Tripathy D, Schneider B, Cirrincione C, Barry W, Hurria A. Identifying risk factors for toxicity in patients (Pts) with hormone-receptor positive (HR+) advanced breast cancer treated with bevacizumab plus letrozole: A CALGB 40503 (Alliance) correlative study. Journal Of Clinical Oncology 2016, 34: 10047-10047. DOI: 10.1200/jco.2016.34.15_suppl.10047.Peer-Reviewed Original Research
2015
Role of vascular density and normalization in response to neoadjuvant bevacizumab and chemotherapy in breast cancer patients
Tolaney SM, Boucher Y, Duda DG, Martin JD, Seano G, Ancukiewicz M, Barry WT, Goel S, Lahdenrata J, Isakoff SJ, Yeh ED, Jain SR, Golshan M, Brock J, Snuderl M, Winer EP, Krop IE, Jain RK. Role of vascular density and normalization in response to neoadjuvant bevacizumab and chemotherapy in breast cancer patients. Proceedings Of The National Academy Of Sciences Of The United States Of America 2015, 112: 14325-14330. PMID: 26578779, PMCID: PMC4655544, DOI: 10.1073/pnas.1518808112.Peer-Reviewed Original ResearchConceptsPathologic complete responseBreast cancer patientsMicrovascular densityInterstitial fluid pressureNeoadjuvant bevacizumabBevacizumab monotherapyPathologic responseCancer patientsImproved pathologic responsePhase II studyPotential predictive biomarkersHER2-negative BCBasal-like subtypePreoperative bevacizumabPaclitaxel chemotherapyII studyComplete responseCombination therapyPredictive biomarkersPlasma biomarkersVascular normalizationBevacizumabVascular densityNew therapiesTissue biopsiesPhase III trial evaluating the addition of bevacizumab to letrozole as first-line endocrine therapy for treatment of hormone-receptor positive advanced breast cancer: CALGB 40503 (Alliance).
Dickler M, Barry W, Cirrincione C, Ellis M, Moynahan M, Innocenti F, Hurria A, Rugo H, Lake D, Hahn O, Schneider B, Tripathy D, Winer E, Hudis C. Phase III trial evaluating the addition of bevacizumab to letrozole as first-line endocrine therapy for treatment of hormone-receptor positive advanced breast cancer: CALGB 40503 (Alliance). Journal Of Clinical Oncology 2015, 33: 501-501. DOI: 10.1200/jco.2015.33.15_suppl.501.Peer-Reviewed Original Research
2013
Differential changes in tissue biomarkers after bevacizumab (BEV) alone in a neoadjuvant study of BEV and chemotherapy in ER+ breast cancer (BC) versus triple-negative breast cancer (TNBC) patients (pts).
Boucher Y, Martin J, Tolaney S, Ancukiewicz M, Seano G, Goel S, Yeh E, Meyer J, Isakoff S, Duda D, Winer E, Krop I, Jain R. Differential changes in tissue biomarkers after bevacizumab (BEV) alone in a neoadjuvant study of BEV and chemotherapy in ER+ breast cancer (BC) versus triple-negative breast cancer (TNBC) patients (pts). Journal Of Clinical Oncology 2013, 31: 1065-1065. DOI: 10.1200/jco.2013.31.15_suppl.1065.Peer-Reviewed Original ResearchMean microvascular densityBreast cancerTissue biomarkersAnti-VEGF antibody bevacizumabTriple-negative breast cancer patientsMP scoresHigher pericyte coveragePhase II studyBreast cancer patientsEffectiveness of chemotherapyActivity of bevacizumabNeoadjuvant bevacizumabNeoadjuvant studiesPrimary endpointII studyPathologic responseBEV treatmentBC subtypesVascular functionAntibody bevacizumabCancer patientsMicrovascular densityPericyte coverageBevacizumabChemotherapy
2012
CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.15_suppl.cra1002.Peer-Reviewed Original Research
2010
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, Miller K, Carey L, Rugo H, Ryabin N, Gelman R, Winer E, Wolff A. TBCRC 012: ABCDE, a phase II randomized study of adjuvant bevacizumab, metronomic chemotherapy (CM), diet and exercise after preoperative chemotherapy for breast cancer. Journal Of Clinical Oncology 2010, 28: tps103-tps103. DOI: 10.1200/jco.2010.28.15_suppl.tps103.Peer-Reviewed Original ResearchRandomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer.
Sikov W, Perou C, Golshan M, Collyar D, Berry D, Hahn O, Singh B, Hudis C, Winer E. Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer. Journal Of Clinical Oncology 2010, 28: tps110-tps110. DOI: 10.1200/jco.2010.28.15_suppl.tps110.Peer-Reviewed Original Research
2009
Dose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction
Morris PG, Dickler M, McArthur HL, Traina T, Sugarman S, Lin N, Moy B, Come S, Godfrey L, Nulsen B, Chen C, Steingart R, Rugo H, Norton L, Winer E, Hudis CA, Dang CT. Dose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction. Journal Of Clinical Oncology 2009, 27: 6117-6123. PMID: 19901120, PMCID: PMC3664032, DOI: 10.1200/jco.2008.20.2952.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCardiac ElectrophysiologyChemotherapy, AdjuvantCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFilgrastimGranulocyte Colony-Stimulating FactorHeart DiseasesHumansMiddle AgedPaclitaxelPolyethylene GlycolsRecombinant ProteinsStroke VolumeTrastuzumabTreatment OutcomeVentricular Function, LeftConceptsLeft ventricular ejection fractionMedian left ventricular ejection fractionDose-dense ACVentricular ejection fractionEjection fractionBreast cancerHER2-normal breast cancerHER2-positive breast cancerTargeted biologic therapiesAdjuvant doxorubicinConcurrent bevacizumabSame regimenBiologic therapyAsymptomatic declineMedian ageMonth 6Cardiac dysfunctionCardiac safetyLVEF measurementsAngiography scansPatientsEarly riskSequential studyThird weekBevacizumab
2008
A pilot study of adjuvant bevacizumab and chemotherapy after neoadjuvant chemotherapy for high-risk breast cancer
Mayer E, Miller K, Rugo H, Peppercorn J, Carey L, Ryabin N, Josephs K, Winer E, Burstein H. A pilot study of adjuvant bevacizumab and chemotherapy after neoadjuvant chemotherapy for high-risk breast cancer. Journal Of Clinical Oncology 2008, 26: 519-519. DOI: 10.1200/jco.2008.26.15_suppl.519.Peer-Reviewed Original Research