2024
Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03.
Saura C, Cortés J, Modi S, Kim S, Hamilton E, Hurvitz S, Krop I, Curigliano G, Iwata H, Im S, Herbolsheimer P, Karnoub M, Gambhire D, Egorov A, Andre F. Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03. Journal Of Clinical Oncology 2024, 42: 1023-1023. DOI: 10.1200/jco.2024.42.16_suppl.1023.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsHER2+ metastatic breast cancerProgression-free survivalMetastatic breast cancerComplete responsePartial responseT-DXdOverall survivalPooled analysisInterstitial lung disease (ILD)/pneumonitisStable disease (SD)/progressive diseaseProlonged progression-free survivalDuration of responseIndependent central reviewNumerically lower ratesLonger treatment durationMetastatic settingRECIST v1.1Trastuzumab deruxtecanOS outcomesCentral reviewAdverse eventsBreast cancerTreatment durationDrug-related
2021
HER2CLIMB-04: Phase 2 open label trial of tucatinib plus trastuzumab deruxtecan in patients with HER2+ unresectable locally advanced or metastatic breast cancer with and without brain metastases (trial in progress).
Krop I, Ramos J, Zhang C, Hamilton E. HER2CLIMB-04: Phase 2 open label trial of tucatinib plus trastuzumab deruxtecan in patients with HER2+ unresectable locally advanced or metastatic breast cancer with and without brain metastases (trial in progress). Journal Of Clinical Oncology 2021, 39: tps1097-tps1097. DOI: 10.1200/jco.2021.39.15_suppl.tps1097.Peer-Reviewed Original ResearchHuman epidermal growth factor receptor 2Metastatic breast cancerProgression-free survivalDisease control rateDuration of responseBrain metastasesOverall survivalT-DXdEpidermal growth factor receptorRECIST v1.1Metastatic settingTrastuzumab deruxtecanBreast cancerOpen-label phase 2 trialPhase 2 open-label trialSmall molecule tyrosine kinase inhibitorsTopoisomerase I inhibitor payloadTreatment of HER2Epidermal growth factor receptor 2Molecule tyrosine kinase inhibitorsHuman epidermal growth factor receptorActive brain metastasesCombination of tucatinibSolid Tumors v1.1Objective response rate
2020
SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer.
Beckwith H, Medgyesy D, Abraham J, Nanda R, Tkaczuk K, Krop I, Pusztai L, Modi S, Mita M, Specht J, Hurvitz S, Han H, Kalinsky K, Wilks S, O'Shaughnessy J, Hart L, Rugo H, Mitri Z, Garfin P, Burris III H. SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer. Journal Of Clinical Oncology 2020, 38: tps1104-tps1104. DOI: 10.1200/jco.2020.38.15_suppl.tps1104.Peer-Reviewed Original ResearchMetastatic breast cancerMonomethyl auristatin EDose-expansion cohortsAntibody-drug conjugatesDose escalationBreast cancerRECIST v1.1Expansion cohortPrior linesCytotoxic chemotherapyMetastatic triple-negative breast cancerGrade 2 peripheral neuropathyInvestigational antibody-drug conjugateNegative metastatic breast cancerLIV-1Triple-negative breast cancerAdequate organ functionHumanized IgG1 monoclonal antibodyKey efficacy endpointsPrimary safety endpointProgression-free survivalDose-limiting toxicityDuration of responseOverall response rateMonths of completion
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 lesions
2018
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer
Dickler MN, Saura C, Richards DA, Krop IE, Cervantes A, Bedard PL, Patel MR, Pusztai L, Oliveira M, Cardenas AK, Cui N, Wilson TR, Stout TJ, Wei MC, Hsu JY, Baselga J. Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer. Clinical Cancer Research 2018, 24: 4380-4387. PMID: 29793946, PMCID: PMC6139036, DOI: 10.1158/1078-0432.ccr-18-0613.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleFulvestrantHumansImidazolesMiddle AgedMutationOxazepinesReceptor, ErbB-2Receptors, EstrogenConceptsAdverse eventsClinical activityBreast cancerMutation statusOpen-label phase II studyHR-positive breast cancerHigher objective response rateConfirmatory phase III trialNCI CTCAE v4.0Median treatment durationObjective response ratePhase II studySerious adverse eventsNew safety signalsPhase III trialsPositive breast cancerClin Cancer ResIntramuscular fulvestrantMeasurable diseaseRECIST v1.1II studyIII trialsPostmenopausal womenUnacceptable toxicityTumor response
2016
HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer
Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer 2016, 16: 352. PMID: 27259714, PMCID: PMC4893300, DOI: 10.1186/s12885-016-2385-z.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerProgression-free survivalPhase 2 trialMetastatic breast cancerBreast cancerDisease progressionOverall survivalMM-302Physician's choiceInvestigator-assessed progression-free survivalMetastatic HER2-positive breast cancerRandomized phase 2 trialEpidermal growth factor receptor 2Anthracycline-naïve patientsBackgroundHuman epidermal growth factor receptor 2Objective response rateGrowth factor receptor 2Positive breast cancerAdo-trastuzumab emtansineKey inclusion criteriaFactor receptor 2Quality of lifeOS ratesRECIST v1.1Refractory HER2