2024
TROPION-Breast03: a randomized phase III global trial of datopotamab deruxtecan ± durvalumab in patients with triple-negative breast cancer and residual invasive disease at surgical resection after neoadjuvant therapy
Bardia A, Pusztai L, Albain K, Ciruelos E, Im S, Hershman D, Kalinsky K, Isaacs C, Loirat D, Testa L, Tokunaga E, Wu J, Dry H, Barlow W, Kozarski R, Maxwell M, Harbeck N, Sharma P. TROPION-Breast03: a randomized phase III global trial of datopotamab deruxtecan ± durvalumab in patients with triple-negative breast cancer and residual invasive disease at surgical resection after neoadjuvant therapy. Therapeutic Advances In Medical Oncology 2024, 16: 17588359241248336. PMID: 38686016, PMCID: PMC11057345, DOI: 10.1177/17588359241248336.Peer-Reviewed Original ResearchInvasive disease-free survivalResidual invasive diseasePathological complete responseTriple-negative breast cancerDisease-free survivalNeoadjuvant therapyInvasive diseaseSurgical resectionBreast cancerHigh risk of disease recurrenceTopoisomerase I inhibitor payloadRisk of disease recurrenceStandard-of-care therapyAdjuvant treatment approachesPhase III studyTreatment of patientsWritten informed consentAntibody-drug conjugatesAged 18-yearsComplete responseNeoadjuvant treatmentInstitutional review boardOverall survivalDisease recurrenceIII studies
2023
LBA3 Phase III study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer (TNBC): KEYNOTE-522 Korean subgroup analysis
Park Y, Im S, Ahn J, Kim M, Cortés J, Dent R, Pusztai L, McArthur H, Kummel S, Denkert C, O'Shaughnessy J, Mouret-Reynier M, Ferreira M, Cortes M, Boileau J, Hui R, Zhu Y, Pan W, Karantza V, Schmid P. LBA3 Phase III study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer (TNBC): KEYNOTE-522 Korean subgroup analysis. Annals Of Oncology 2023, 34: s1467-s1468. DOI: 10.1016/j.annonc.2023.10.132.Peer-Reviewed Original Research
2021
VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. placebo for early-stage TNBC
Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Ding Y, Tryfonidis K, Aktan G, Karantza V, O’Shaughnessy J. VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. placebo for early-stage TNBC. Annals Of Oncology 2021, 32: 1198-1200. DOI: 10.1016/j.annonc.2021.06.014.Peer-Reviewed Original Research
2019
LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC)
Schmid P, Cortés J, Dent R, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching P, Cardoso F, Jia L, Karantza V, Zhao J, Aktan G, O’Shaughnessy J. LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC). Annals Of Oncology 2019, 30: v853-v854. DOI: 10.1093/annonc/mdz394.003.Peer-Reviewed Original ResearchEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalSubsidiary of MerckGerman Study GroupBristol-Myers SquibbPD-L1Dohme Corp.Daiichi SankyoSeattle GeneticsChemo groupYpT0 ypN0Merck SharpGenomic HealthStudy groupFavorable trendF. Hoffmann-La Roche LtdCycles of paclitaxelDual primary endpointsI-SPY 2Cycles of doxorubicinPhase III studyWolters Kluwer HealthEli LillyKyowa Hakko Kirin