2024
Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer
Marín-Aguilera M, Jares P, Sanfeliu E, Villacampa G, Hernández-lllán E, Martínez-Puchol A, Shankar S, González-Farré B, Waks A, Brasó-Maristany F, Pardo F, Manning D, Abery J, Curaba J, Moon L, Gordon O, Galván P, Wachirakantapong P, Castillo O, Nee C, Blasco P, Senevirathne T, Sirenko V, Martínez-Sáez O, Aguirre A, Krop I, Li Z, Spellman P, Filho O, Polyak K, Michaels P, Puig-Butillé J, Vivancos A, Matito J, Buckingham W, Perou C, Villagrasa-González P, Prat A, Parker J, Paré L. Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer. ESMO Open 2024, 9: 102903. PMID: 38452436, PMCID: PMC10937240, DOI: 10.1016/j.esmoop.2024.102903.Peer-Reviewed Original ResearchConceptsEarly-stage HER2-positive breast cancerHER2-positive breast cancerTumor cell contentBreast cancerRecurrence riskEarly-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancerHuman epidermal growth factor receptor 2 (HER2)-positive breast cancerLow tumor cell contentBreast cancer recurrence riskERBB2 mRNA expressionFormalin-fixed paraffin-embedded (FFPE) tumor tissuesPost-neoadjuvant therapyCancer recurrence riskFFPE tumor samplesGenomic testingReagent lotsMessenger RNAProtocol variationsRNA extraction kitsFFPE tumorsHER2DXCell contentTumor samplesIntratumoral variabilityTumor tissues
2022
Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer
Waks AG, Keenan TE, Li T, Tayob N, Wulf GM, Richardson ET, Attaya V, Anderson L, Mittendorf EA, Overmoyer B, Winer EP, Krop IE, Agudo J, Van Allen EM, Tolaney SM. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Journal For ImmunoTherapy Of Cancer 2022, 10: e005119. PMID: 36252998, PMCID: PMC9577940, DOI: 10.1136/jitc-2022-005119.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMetastatic breast cancerAdverse eventsBreast cancerT-DM1Immune biomarkersTrastuzumab emtansineHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerGrade 3 adverse eventsMedian progression-free survivalTreatment-related adverse eventsHuman epidermal growth factor receptor 2Cell death ligand 1HER2-positive breast cancerEpidermal growth factor receptor 2Dose-finding cohortPhase 2 dosePhase Ib studyPhase Ib trialAnti-HER2 therapyDose-limiting toxicityGrowth factor receptor 2Immune checkpoint blockade