2020
TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker
Mayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Annals Of Oncology 2020, 31: 1518-1525. PMID: 32798689, PMCID: PMC8437015, DOI: 10.1016/j.annonc.2020.08.2064.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerHomologous recombination deficiencyPhase II studyPathologic responsePreoperative cisplatinII studyBreast cancerProspective phase II studyEffective predictive biomarkersInadequate clinical responsePreoperative chemotherapy regimenSingle-agent cisplatinHomologous recombination deficiency biomarkersGermline BRCA1/2Preoperative paclitaxelChemotherapy regimenClinical responseCisplatin chemotherapyPredictive biomarkersAlternative chemotherapyPreoperative trialInadequate responseHRD scoreStage IBaseline tissueTBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial).
Tung N, Arun B, Hacker MR, Hofstatter E, Toppmeyer DL, Isakoff SJ, Borges V, Legare RD, Isaacs C, Wolff AC, Marcom PK, Mayer EL, Lange PB, Goss AJ, Jenkins C, Krop IE, Winer EP, Schnitt SJ, Garber JE. TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial). Journal Of Clinical Oncology 2020, 38: 1539-1548. PMID: 32097092, PMCID: PMC8462533, DOI: 10.1200/jco.19.03292.Peer-Reviewed Original ResearchConceptsHER2-negative breast cancerTriple-negative breast cancerResidual cancer burden scoreBreast cancerDoxorubicin-cyclophosphamideRisk ratioStage IPathologic complete response rateHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Single-agent cisplatinComplete response ratePhase II studyPhase II trialGrowth factor receptor 2Positive breast cancerNegative breast cancerFactor receptor 2CT1-3II trialII studyNodal involvementPCR rateNegative diseasePathologic response
2019
HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.
Metzger Filho O, Viale G, Trippa L, Li T, Yardley D, Mayer I, Abramson V, Arteaga C, Spring L, Waks A, Janiszewska M, Wrabel E, Demeo M, Bardia A, King T, Polyak K, Winer E, Krop I. HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial. Journal Of Clinical Oncology 2019, 37: 502-502. DOI: 10.1200/jco.2019.37.15_suppl.502.Peer-Reviewed Original ResearchPathologic complete responseER statusRCB 0T-DM1HER2 heterogeneitySignificant associationUltrasound-guided core biopsyRoutine pathology evaluationMedian tumor sizeProspective clinical trialsPredictors of responseAreas of tumorHigh rateCurative settingRCB-IIRCB-IIIPrimary endpointComplete responseHER2 positivityPathologic responseTherapy regimenEvaluable casesTumor sizeCore biopsyClinical trialsTBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker.
Mayer E, Abramson V, Jankowitz R, Falkson C, Marcom P, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Perou C, Richardson A, Tung N, Barry W, Tan-Wasielewski Z, Timms K, Hartman A, Wolff A, Winer E. TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker. Journal Of Clinical Oncology 2019, 37: 507-507. DOI: 10.1200/jco.2019.37.15_suppl.507.Peer-Reviewed Original ResearchPhase II studyII studyPreoperative chemotherapyHRD scoreRandomized phase II studyOne-sided type I errorCo-primary objectivesNew safety signalsSimilar response ratesHomologous recombination deficiency biomarkersPreoperative cisplatinTNBC cohortPathologic responseRCB 0Evaluable specimensPredictive biomarkersAlternative chemotherapySpecific chemotherapySafety signalsArm CCT armChemotherapyStage IResponse rateBaseline tissue
2017
Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer (BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev).
Waks A, Barry W, Gjini E, Dillon D, Rodig S, Brock J, Baltay M, Savoie J, Stover D, Winer E, Krop I, Tolaney S. Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer (BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev). Journal Of Clinical Oncology 2017, 35: e12134-e12134. DOI: 10.1200/jco.2017.35.15_suppl.e12134.Peer-Reviewed Original ResearchTumor-infiltrating lymphocytesTPD-L1Miller-PaynePathologic responseImmune biomarkersHormone receptor-positive breast cancer patientsReceptor-positive breast cancer patientsPanCancer Immune Profiling PanelResidual cancer burden scorePathologic complete responsePD-L1 expressionBreast cancer patientsPD-L1 scoresImmune Profiling PanelImportant clinical implicationsPreoperative chemotherapyComplete responseProspective trialTumor-immune interactionsBurden scoreCancer patientsImmune microenvironmentUnadjusted analysesTumor gradeTreatment outcomes
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 biopsies
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
A phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense (dd) doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC).
Tolaney S, Duda D, Boucher Y, Goel S, Martin J, Ancukiewicz M, Potler H, Incio J, Ligibel J, Isakoff S, Fukumura D, Winer E, Krop I, Jain R. A phase II study of preoperative (preop) bevacizumab (bev) followed by dose-dense (dd) doxorubicin (A)/cyclophosphamide (C)/paclitaxel (T) in combination with bev in HER2-negative operable breast cancer (BC). Journal Of Clinical Oncology 2012, 30: 1026-1026. DOI: 10.1200/jco.2012.30.15_suppl.1026.Peer-Reviewed Original ResearchTN breast cancerBreast cancerInterstitial fluid pressureMiller-PayneTN tumorsHER2-negative operable breast cancerMean interstitial fluid pressureHormone receptorsMP responseAddition of BevAxillary LN involvementDose-dense doxorubicinTriple-negative cohortOperable breast cancerPhase II studyPredictors of responseMean vascular densityPreoperative bevacizumabLN involvementII studyOverall cohortPathologic responseBiomarker predictorsNegative cohortPharmacodynamic effects