2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse eventsTBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).
Tung N, Robson M, Ventz S, Santa-Maria C, Marcom P, Nanda R, Shah P, Ballinger T, Yang E, Melisko M, Brufsky A, Vinayak S, Demeo M, Jenkins C, Domchek S, Wulf G, Krop I, Wolff A, Winer E, Garber J. TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded). Journal Of Clinical Oncology 2020, 38: 1002-1002. DOI: 10.1200/jco.2020.38.15_suppl.1002.Peer-Reviewed Original Research
2015
Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)
Lin NU, Guo H, Yap JT, Mayer IA, Falkson CI, Hobday TJ, Dees EC, Richardson AL, Nanda R, Rimawi MF, Ryabin N, Najita JS, Barry WT, Arteaga CL, Wolff AC, Krop IE, Winer EP, Van den Abbeele AD. Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003). Journal Of Clinical Oncology 2015, 33: 2623-2631. PMID: 26169615, PMCID: PMC4534525, DOI: 10.1200/jco.2014.60.0353.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCohort StudiesFemaleFluorodeoxyglucose F18HumansLapatinibMiddle AgedNeoplasm MetastasisPositron-Emission TomographyQuinazolinesReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsMetastatic breast cancerHuman epidermal growth factor receptorClinical benefit rateEpidermal growth factor receptorObjective response rateProgression-free survivalGrowth factor receptorClinical outcomesWeek 1Cohort 2Benefit rateCohort 1Breast cancerFactor receptorPredictive valueResponse rateConfirmed objective response rateMedian progression-free survivalEnd pointPhase II studyPrimary end pointSecondary end pointsSelection of patientsToxicity of chemotherapyPET/CT
2013
Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction
Kansal KJ, Dominici LS, Tolaney SM, Isakoff SJ, Smith BL, Jiang W, Brock JE, Winer EP, Krop IE, Golshan M. Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction. Breast Cancer Research And Treatment 2013, 141: 255-259. PMID: 24026859, DOI: 10.1007/s10549-013-2682-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsFemaleHumansMammaplastyMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPostoperative ComplicationsTreatment OutcomeYoung AdultConceptsSurgical complicationsAC/TPostoperative complicationsComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerOverall complication rateRate of complicationsThird of patientsCohort of patientsSame healthcare systemSingle-arm trialFisher's exact testUse of BevTerms of demographicsNeoadjuvant bevacizumabNeoadjuvant therapyImplant reconstructionMastectomyNeoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction.
Kansal K, Dominici L, Tolaney S, Isakoff S, Krop I, Smith B, Jiang W, Potler H, Brock J, Winer E, Golshan M. Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction. Journal Of Clinical Oncology 2013, 31: 1100-1100. DOI: 10.1200/jco.2013.31.15_suppl.1100.Peer-Reviewed Original ResearchSurgical complicationsAC/TNeoadjuvant bevacizumabNeoadjuvant therapyComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerUse of bevacizumabOverall complication rateRate of complicationsThird of patientsCohort of patientsSingle-arm trialSame healthcare systemFisher's exact testTerms of demographicsNon-randomized dataPostoperative complicationsImplant reconstructionProspective clinical experience with research biopsies in breast cancer patients.
Zeghibe C, Luis I, Frank E, Sohl J, Washington K, Silverman S, Fonte J, Mayer E, Overmoyer B, Richardson A, Krop I, Winer E, Lin N. Prospective clinical experience with research biopsies in breast cancer patients. Journal Of Clinical Oncology 2013, 31: e17574-e17574. DOI: 10.1200/jco.2013.31.15_suppl.e17574.Peer-Reviewed Original ResearchResearch biopsiesAdverse eventsBreast cancerCohort 1Cohort 2Grade 2Dana-Farber Cancer InstituteGrade 2 painGrade 3 painProspective clinical experienceSingle institution experienceTime of diagnosisBreast cancer patientsOngoing prospective studyMajority of ptsAcademic medical centerWithdrew consentAnalytic cohortChart reviewFirst recurrenceMetastatic diseasePerformance statusSevere painInstitution experienceProspective studyA phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer
Tolaney SM, Najita J, Sperinde J, Huang W, Chen WY, Savoie J, Fornier M, Winer EP, Bunnell C, Krop IE. A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer. Annals Of Oncology 2013, 24: 1841-1847. PMID: 23559151, PMCID: PMC3690910, DOI: 10.1093/annonc/mdt121.Peer-Reviewed Original ResearchConceptsMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepilonePhase II studyBreast cancerII studyMetastatic diseaseCohort 2Cohort 1Treatment-related toxic effectsClinical benefit rateSubsequent-line therapyTrastuzumab-containing regimensMetastatic breast cancerPrior chemotherapyLine therapyBenefit rateOverall RRDay 1PatientsTrastuzumabIxabepiloneCancerTumor biomarkersCohort
2009
A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer.
Tolaney S, Najita J, Chen W, Savoie J, Fornier M, Krop I, Winer E, Bunnell C. A phase II study of ixabepilone plus trastuzumab for metastatic HER2-positive breast cancer. Cancer Research 2009, 69: 3137. DOI: 10.1158/0008-5472.sabcs-3137.Peer-Reviewed Original ResearchMetastatic HER2-positive breast cancerHER2-positive breast cancerCombination of ixabepiloneBreast cancerPartial responseCohort 1Response rateMetastatic diseaseCohort 2Clinical benefit rateHigher cardiac toxicityRefractory breast cancerSubsequent-line therapyTrastuzumab-containing regimensCycles of therapyPhase II studyTreatment-related toxicityCohort of patientsEncouraging response ratesMetastatic breast cancerSame treatment regimenOverall response ratePrior chemotherapyStable diseaseElevated transaminases