2020
PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Gnant M, DeMichele A, Martin M, Burstein H, Prat A, Rubovszky G, Miller K, Pfeiler G, Winer E, Zdenkowski N, Anderson D, Nowecki Z, Loibl S, Fohler H, Metzger O, Fumagalli D, Theall K, Fesl C, Dueck A. PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2020, 31: s1145. DOI: 10.1016/j.annonc.2020.08.2240.Peer-Reviewed Original Research
2018
369TiP PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + Anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC)
Loibl S, Metzger O, Mandrekar S, Mundhenke C, Seiler S, Valagussa P, DeMichele A, Lim E, Tripathy D, Winer E, Huang C, Carey L, Francis P, Miller K, Goetz M, Prat A, Loi S, Krop I, Gianni L, Ciruelos E. 369TiP PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + Anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC). Annals Of Oncology 2018, 29: viii121. DOI: 10.1093/annonc/mdy272.357.Peer-Reviewed Original ResearchA phase I study of palbociclib (PALBO) plus everolimus (EVE) and exemestane (EXE) in hormone-receptor positive (HR+)/HER2- metastatic breast cancer (MBC) after progression on a CDK4/6 inhibitor (CDK4/6i): safety, tolerability and pharmacokinetic (PK) analysis.
Barroso-Sousa R, Guo H, Barry W, Ferreira A, Rees R, Winer E, Wagle N, Tolaney S. A phase I study of palbociclib (PALBO) plus everolimus (EVE) and exemestane (EXE) in hormone-receptor positive (HR+)/HER2- metastatic breast cancer (MBC) after progression on a CDK4/6 inhibitor (CDK4/6i): safety, tolerability and pharmacokinetic (PK) analysis. Journal Of Clinical Oncology 2018, 36: 1068-1068. DOI: 10.1200/jco.2018.36.15_suppl.1068.Peer-Reviewed Original ResearchPalbociclib after CDK and endocrine therapy (PACE): A randomized phase II study of fulvestrant, palbociclib, and avelumab for endocrine pre-treated ER+/HER2- metastatic breast cancer.
Mayer E, Wander S, Regan M, DeMichele A, Forero-Torres A, Rimawi M, Ma C, Cristofanilli M, Anders C, Bartlett C, Winer E, Burstein H. Palbociclib after CDK and endocrine therapy (PACE): A randomized phase II study of fulvestrant, palbociclib, and avelumab for endocrine pre-treated ER+/HER2- metastatic breast cancer. Journal Of Clinical Oncology 2018, 36: tps1104-tps1104. DOI: 10.1200/jco.2018.36.15_suppl.tps1104.Peer-Reviewed Original Research
2017
324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer
Metzger O, Mandrekar S, Ciruelos E, Loibl S, Valagussa P, Demichele A, Lim E, Tripathy D, Winer E, Huang C, Khoeler M, Carey L, Francis P, Miller K, Goel S, Goetz M, Prat A, Loi S, Krop I, Gianni L. 324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer. Annals Of Oncology 2017, 28: v107-v108. DOI: 10.1093/annonc/mdx365.087.Peer-Reviewed Original Research215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Demichele A, Pfeiler G, Barry W, Metzger O, Rastogi P, Symmans F, Burstein H, Miller K, Loibl S, Schmatloch S, Goulioti T, Zardavas D, Fesl C, Koehler M, Bartlett C, Huang X, Piccart M, Winer E, Gnant M. 215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2017, 28: v66. DOI: 10.1093/annonc/mdx362.064.Peer-Reviewed Original Research
2014
Adjuvant palbociclib (P) plus endocrine therapy (ET) for hormone receptor positive (HR+) breast cancer: A phase II feasibility study.
Mayer E, Gropper A, Tung N, Higgins M, Traina T, Barry W, Winer E, Burstein H. Adjuvant palbociclib (P) plus endocrine therapy (ET) for hormone receptor positive (HR+) breast cancer: A phase II feasibility study. Journal Of Clinical Oncology 2014, 32: tps654-tps654. DOI: 10.1200/jco.2014.32.15_suppl.tps654.Peer-Reviewed Original Research