2020
TBCRC023: A Randomized Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab Without Chemotherapy for 12 versus 24 Weeks in Patients with HER2-Positive Breast Cancer
Rimawi MF, Niravath P, Wang T, Rexer BN, Forero A, Wolff AC, Nanda R, Storniolo AM, Krop I, Goetz MP, Nangia JR, Jiralerspong S, Pavlick A, Veeraraghavan J, De Angelis C, Gutierrez C, Schiff R, Hilsenbeck SG, Osborne CK, Consortium O. TBCRC023: A Randomized Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab Without Chemotherapy for 12 versus 24 Weeks in Patients with HER2-Positive Breast Cancer. Clinical Cancer Research 2020, 26: 821-827. PMID: 31662331, DOI: 10.1158/1078-0432.ccr-19-0851.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerPathologic complete responseDual anti-HER2 therapyAnti-HER2 therapyBreast cancerEstrogen receptorNeoadjuvant trialsPhase II neoadjuvant trialRandomized phase II trialHER2-positive breast tumorsDeescalation of therapyER-positive subgroupMedian tumor sizePhase II trialPhase II designAcneiform rashEvaluable patientsCommon toxicitiesII trialComplete responseMedian ageStudy treatmentTumor sizeExperimental armPatients
2019
HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.
Metzger Filho O, Viale G, Trippa L, Li T, Yardley D, Mayer I, Abramson V, Arteaga C, Spring L, Waks A, Janiszewska M, Wrabel E, Demeo M, Bardia A, King T, Polyak K, Winer E, Krop I. HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial. Journal Of Clinical Oncology 2019, 37: 502-502. DOI: 10.1200/jco.2019.37.15_suppl.502.Peer-Reviewed Original ResearchPathologic complete responseER statusRCB 0T-DM1HER2 heterogeneitySignificant associationUltrasound-guided core biopsyRoutine pathology evaluationMedian tumor sizeProspective clinical trialsPredictors of responseAreas of tumorHigh rateCurative settingRCB-IIRCB-IIIPrimary endpointComplete responseHER2 positivityPathologic responseTherapy regimenEvaluable casesTumor sizeCore biopsyClinical trials