2023
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases
Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases. JAMA Oncology 2023, 9: 197-205. PMID: 36454580, PMCID: PMC9716438, DOI: 10.1001/jamaoncol.2022.5610.Peer-Reviewed Original ResearchConceptsErbB2-positive metastatic breast cancerMetastatic breast cancerPlacebo-combination groupPositive metastatic breast cancerNew brain lesionsBrain metastasesOverall survivalSubgroup analysisBrain lesionsBreast cancerIntracranial progression-free survivalPlacebo-controlled clinical trialIntracranial objective response rateStable brain metastasesMedian overall survivalObjective response rateProgression-free survivalExploratory subgroup analysisGreater clinical benefitCNS-PFSHER2CLIMB trialIntracranial outcomesFirst progressionMedian ageClinical benefit
2020
53. TUCATINIB VS PLACEBO ADDED TO TRASTUZUMAB AND CAPECITABINE FOR PATIENTS WITH PREVIOUSLY TREATED HER2+ METASTATIC BREAST CANCER (MBC) WITH BRAIN METASTASES (BM) (HER2CLIMB)
Lin N, Murthy R, Anders C, Borges V, Hurvitz S, Loi S, Abramson V, Bedard P, Oliveira M, Zelnack A, DiGiovanna M, Bachelot T, Chien A, O’Regan R, Wardley A, Mueller V, Carey L, McGoldrick S, An X, Winer E. 53. TUCATINIB VS PLACEBO ADDED TO TRASTUZUMAB AND CAPECITABINE FOR PATIENTS WITH PREVIOUSLY TREATED HER2+ METASTATIC BREAST CANCER (MBC) WITH BRAIN METASTASES (BM) (HER2CLIMB). Neuro-Oncology Advances 2020, 2: ii11-ii11. PMCID: PMC7401403, DOI: 10.1093/noajnl/vdaa073.041.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesCNS-PFSSecond progressionControl armEfficacy analysisBrain progressionExploratory efficacy analysesMedian CNS-PFSBaseline brain MRIMedian OSOverall deathRECIST 1.1Study therapyMedian timeInvestigator's evaluationIC diseaseLocal treatmentBreast cancerBrain MRIReduced riskCapecitabineTrastuzumabTucatinibHER2Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial
Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O’Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. Journal Of Clinical Oncology 2020, 38: 2610-2619. PMID: 32468955, PMCID: PMC7403000, DOI: 10.1200/jco.20.00775.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBrain metastasesProgression-free survivalRisk of deathBreast cancerOverall survivalControl armCNS-PFSIntracranial efficacyIntracranial progressionBaseline brain magnetic resonance imagingHuman epidermal growth factor receptor 2Intracranial objective response rateEpidermal growth factor receptor 2Brain magnetic resonance imagingMedian CNS-PFSRECIST 1.1 criteriaMedian overall survivalObjective response rateGrowth factor receptor 2Positive breast cancerFactor receptor 2Magnetic resonance imagingHER2CLIMB trialImproved antitumor activityTucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB).
Lin N, Murthy R, Anders C, Borges V, Hurvitz S, Loi S, Abramson V, Bedard P, Oliveira M, Zelnak A, DiGiovanna M, Bachelot T, Chien A, O'Regan R, Wardley A, Müller V, Carey L, McGoldrick S, An G, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2020, 38: 1005-1005. DOI: 10.1200/jco.2020.38.15_suppl.1005.Peer-Reviewed Original ResearchMetastatic breast cancerProgression-free survivalObjective response rateBrain metastasesOverall survivalCNS-PFSControl armSecond progressionEfficacy analysisBrain progressionLocal treatmentBreast cancerProlongation of PFSMedian progression-free survivalExploratory efficacy analysesMedian CNS-PFSMedian overall survivalBaseline brain MRIHER2 kinase inhibitorDeath overallRECIST 1.1Study therapyFree survivalInvestigator's evaluationIC disease