2022
Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]. Annals Of Oncology 2022, 34: 630. PMID: 36564285, DOI: 10.1016/j.annonc.2022.12.005.Peer-Reviewed Original Research
2020
49MO IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer
Iwata H, Emens L, Adams S, Barrios C, Diéras V, Loi S, Rugo H, Schneeweiss A, Winer E, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Chui S, Schmid P. 49MO IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer. Annals Of Oncology 2020, 31: s1261-s1262. DOI: 10.1016/j.annonc.2020.10.069.Peer-Reviewed Original ResearchIMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer
Emens L, Adams S, Barrios C, Dieras V, Iwata H, Loi S, Rugo H, Schneeweiss A, Winer E, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Chui S, Schmid P. IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer. Annals Of Oncology 2020, 31: s1148. PMCID: PMC7506448, DOI: 10.1016/j.annonc.2020.08.2244.Peer-Reviewed Original Research137O Tucatinib vs placebo added to trastuzumab and capecitabine in previously treated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB)
Curigliano G, Murthy R, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz S, Cameron D, Borges V, Bedard P, Oliveira M, Jakobsen E, Bachelot T, Shachar S, Mueller V, Carey L, Loibl S, Feng W, Walker L, Winer E. 137O Tucatinib vs placebo added to trastuzumab and capecitabine in previously treated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Annals Of Oncology 2020, 31: s62-s63. DOI: 10.1016/j.annonc.2020.03.238.Peer-Reviewed Original Research
2019
Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O’Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Annals Of Oncology 2019, 30: 1842. PMID: 31407010, PMCID: PMC6927326, DOI: 10.1093/annonc/mdz215.Peer-Reviewed Original ResearchFirst-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results.
O'Shaughnessy J, Campone M, Andre F, Nusch A, Grischke E, Villanueva C, Marschner N, Winer E, Paluch-Shimon S, Rodriguez-Lorenc K, Hilliard A, Le Gac F, Ridolfi A, Hortobagyi G. First-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results. Journal Of Clinical Oncology 2019, 37: 1078-1078. DOI: 10.1200/jco.2019.37.15_suppl.1078.Peer-Reviewed Original ResearchGrade adverse eventsAdverse eventsLET armMedian durationHER2- advanced breast cancerLong-term safety resultsLong-term safety dataFirst-line ribociclibMONALEESA-2 studyCommon adverse eventsMo of exposureMONALEESA-2Data cutoffGI disordersPostmenopausal womenSafety profileProlonged QTQT intervalBreast cancerSafety dataSafety resultsSudden deathDose reductionPlaceboCommon reasonIMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Henschel V, Molinero L, Chui S, Husain A, Winer E, Loi S, Emens L. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1003-1003. DOI: 10.1200/jco.2019.37.15_suppl.1003.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerOverall survivalPD-L1OS analysisTriple-negative breast cancerECOG PS 0Median overall survivalPrimary PFS analysisPD-L1 testingPhase III studyCo-primary endpointsEligible ptsOS benefitData cutoffIII studyNab-paclitaxelPS 0AtezoBreast cancerPFS analysisPlaceboNP armTumor tissueSafety updateOS data
2018
LBA1_PR IMpassion130: Results from a global, randomised, double-blind, phase III study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC)
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Hegg R, Im S, Wright G, Henschel V, Molinero L, Chui S, Funke R, Husain A, Winer E, Loi S, Emens L. LBA1_PR IMpassion130: Results from a global, randomised, double-blind, phase III study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC). Annals Of Oncology 2018, 29: viii707-viii708. DOI: 10.1093/annonc/mdy424.008.Peer-Reviewed Original ResearchA randomized study of tucatinib (ONT-380) vs. placebo in combination with capecitabine and trastuzumab in patients with pretreated HER2-pos. metastatic breast cancer: HER2CLIMB
Müller V, Park-Simon T, Huober J, Schmidt M, Weide R, Reinisch M, Fehm T, Salat C, Loibl S, Mundhenke C, Winer E. A randomized study of tucatinib (ONT-380) vs. placebo in combination with capecitabine and trastuzumab in patients with pretreated HER2-pos. metastatic breast cancer: HER2CLIMB. Geburtshilfe Und Frauenheilkunde 2018, 78: 245-245. DOI: 10.1055/s-0038-1671504.Peer-Reviewed Original ResearchABC trial (A011502): Randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for breast cancer.
Chen W, Winer E, Barry W, Partridge A, Carey L, Carvan M, Matyka C, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): Randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for breast cancer. Journal Of Clinical Oncology 2018, 36: tps597-tps597. DOI: 10.1200/jco.2018.36.15_suppl.tps597.Peer-Reviewed Original Research
2016
136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC
Emens L, Adams S, Loi S, Schneeweiss A, Rugo H, Winer E, Barrios C, Dieras V, de la Haba-Rodriguez J, Gianni L, Kusuma N, Chui S, Schmid P. 136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC. Annals Of Oncology 2016, 27 DOI: 10.1093/annonc/mdw577.019.Peer-Reviewed Original Research136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC
Emens L, Adams S, Loi S, Schneeweiss A, Rugo H, Winer E, Barrios C, Dieras V, de la Haba-Rodriguez J, Gianni L, Kusuma N, Chui S, Schmid P. 136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC. Annals Of Oncology 2016, 27: ix40. DOI: 10.1016/s0923-7534(21)00294-5.Peer-Reviewed Original Research