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
2021
A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer.
O'Sullivan C, Ballman K, McCall L, Zemla T, Weiss A, Mitchell M, Blinder V, Tung N, Irvin W, Lee M, Goetz M, Symmans W, Borges V, Krop I, Partridge A, Carey L. A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Journal Of Clinical Oncology 2021, 39: tps595-tps595. DOI: 10.1200/jco.2021.39.15_suppl.tps595.Peer-Reviewed Original ResearchInvasive disease-free survivalEarly breast cancerTyrosine kinase inhibitorsAdjuvant T-DM1Neoadjuvant therapyPathologic complete responseDisease-free survivalResidual diseaseT-DM1Postoperative chemotherapyAdjuvant radiationBreast cancerHER2-positive invasive breast cancerBrain metastasis-free survivalBreast cancer-free survivalPathologic lymph node statusDistant recurrence-free survivalClinical stage IIInvasive residual diseasePost-neoadjuvant therapyCancer-free survivalDe-escalation trialsLymph node statusRecurrence-free survivalSelective tyrosine kinase inhibitor