Studies & Results
TRIO018
Phase 1/2, Open-label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991 (Oral Cdk 4/6 Inhibitor) And Letrozole Single Agent For The First-line Treatment Of Er Positive, Her2 Negative Advanced Breast Cancer In Postmenopausal Women
View FDA Study View EU Study
Presentations
San Antonio Breast Cancer Symposium, 2020
Finn RS, et al.
Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18)
ASCO Annual Meeting, 2015
Crown J, Finn RS, Ettl J, et al
Efficacy and safety of first-line palbociclib plus letrozole compared with letrozole alone in patients aged ≥ 65 years with estrogen receptor-positive, HER2-negative advanced breast cancer: A subgroup analysis by age of the PALOMA-1/TRIO-18 trial.
ASCO Annual Meeting, 2015
Finn RS, Crown J, Ettl J, et al
Clinical efficacy and safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment in patients (pts) with ER+ and HER2- advanced breast cancer (ABC) who have not received any systemic treatment (ST): A subgroup analysis of PALOMA-1/TRIO-18.
ASCO Annual Meeting, 2015
Finn RS, Crown JS, Lang I, et al
The effect of palbociclib (P) in combination with letrozole (L) on bone metastases in women with ER+/ HER2- metastatic breast cancer (MBC): Subanalysis from a randomized phase II study.
ASCO Annual Meeting, 2015
Slamon DJ, Crown J, Lang I, et al
Long-term safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment for postmenopausal patients with ER+ and HER2- advanced breast cancer (ABC) (PALOMA-1/TRIO-18).
San Antonio Breast Cancer Symposium, 2014
Bell T, Crown JP, Lang I, et al
Impact of adding palbociclib to letrozole on pain severity and pain interference with various activities of daily life in patients with ER+, HER2- metastatic breast cancer as first line treatment.
ESMO/ECCO Congress, 2014
Finn R, Crown J, Ettl J, et al
Clinical Patterns of Palbociclib Associated Neutropenia in the Paloma-1/Trio-18 Trial.
AACR Annual Meeting, 2014
Finn RS, Crown JP, Lang I, et al
Final results of a randomized Phase II study of PD 0332991, a cyclin-dependent kinase (CDK)-4/6 inhibitor, in combination with letrozole vs letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1; TRIO-18).
ESMO/ECCO Congress, 2014
Jiang Y, Randolph S, English P, et al
Cell Cycle Biomarker Analysis from the Paloma-1/ Trio 18 Palbociclib Plus Letrozole Phase Ii Study in Er-Positive/Her2-Negative Advanced Breast Cancer (abc).
ESMO/ECCO Congress, 2013
Finn RS, Crown JP, Lang I, et al
Phase II Study of Palbociclib (pd-0332991) + Letrozole Vs Letrozole Alone in First-Line Er + /Her2- Advanced Breast Cancer.
San Antonio Breast Cancer Symposium, 2012
Finn RS, Crown JP, Lang I, et al
Results of a randomized phase 2 study of PD 0332991, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with letrozole vs letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (BC).
ASCO Annual Meeting, 2011
Finn RS, Boer K, Lang I, et al
A randomized phase II study of PD 0332991, cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with letrozole for first-line treatment of patients with postmenopausal, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.
San Antonio Breast Cancer Symposium, 2011
Finn RS, Crown JP, Boer K, et al
Preliminary Results of a Randomized Phase 2 Study of PD 0332991, a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor, in Combination with Letrozole for First-Line Treatment of Patients (pts) with Post-Menopausal, ER+, HER2-Negative (HER2–) Advanced Breast Cancer.
ASCO Annual Meeting, 2010
Slamon DJ, Hurvitz SA, Applebaum S, et al
Phase I study of PD 0332991, cyclin-D kinase (CDK) 4/6 inhibitor in combination with letrozole for first-line treatment of patients with ER-positive, HER2-negative breast cancer.
Publications
Finn RS, Crown JP, Lang I, et al: The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study.
Lancet Oncol 16:25–35, 2015
Spera G, Fresco R, G Spera, et al: Beta Blockers and Improved Progression Free Survival in Patients with Advanced HER2 Negative Breast Cancer: a Retrospective Analysis of the ROSE/TRIO-012 Study.
Ann Oncol mdx264.
Bell T, Crown J, Lang, I, et al: Impact of palbociclib plus letrozole on pain severity and
pain interference with daily activities in patients with ER
+/HER2− advanced breast cancer as first-line treatment.
Curr Med Res Opin 32; 959-965, 2016
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org
Presentations
San Antonio Breast Cancer Symposium, 2020
Finn RS, et al.
Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18)
ASCO Annual Meeting, 2015
Crown J, Finn RS, Ettl J, et al
Efficacy and safety of first-line palbociclib plus letrozole compared with letrozole alone in patients aged ≥ 65 years with estrogen receptor-positive, HER2-negative advanced breast cancer: A subgroup analysis by age of the PALOMA-1/TRIO-18 trial.
ASCO Annual Meeting, 2015
Finn RS, Crown J, Ettl J, et al
Clinical efficacy and safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment in patients (pts) with ER+ and HER2- advanced breast cancer (ABC) who have not received any systemic treatment (ST): A subgroup analysis of PALOMA-1/TRIO-18.
ASCO Annual Meeting, 2015
Finn RS, Crown JS, Lang I, et al
The effect of palbociclib (P) in combination with letrozole (L) on bone metastases in women with ER+/ HER2- metastatic breast cancer (MBC): Subanalysis from a randomized phase II study.
ASCO Annual Meeting, 2015
Slamon DJ, Crown J, Lang I, et al
Long-term safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment for postmenopausal patients with ER+ and HER2- advanced breast cancer (ABC) (PALOMA-1/TRIO-18).
San Antonio Breast Cancer Symposium, 2014
Bell T, Crown JP, Lang I, et al
Impact of adding palbociclib to letrozole on pain severity and pain interference with various activities of daily life in patients with ER+, HER2- metastatic breast cancer as first line treatment.
ESMO/ECCO Congress, 2014
Finn R, Crown J, Ettl J, et al
Clinical Patterns of Palbociclib Associated Neutropenia in the Paloma-1/Trio-18 Trial.
AACR Annual Meeting, 2014
Finn RS, Crown JP, Lang I, et al
Final results of a randomized Phase II study of PD 0332991, a cyclin-dependent kinase (CDK)-4/6 inhibitor, in combination with letrozole vs letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1; TRIO-18).
ESMO/ECCO Congress, 2014
Jiang Y, Randolph S, English P, et al
Cell Cycle Biomarker Analysis from the Paloma-1/ Trio 18 Palbociclib Plus Letrozole Phase Ii Study in Er-Positive/Her2-Negative Advanced Breast Cancer (abc).
ESMO/ECCO Congress, 2013
Finn RS, Crown JP, Lang I, et al
Phase II Study of Palbociclib (pd-0332991) + Letrozole Vs Letrozole Alone in First-Line Er + /Her2- Advanced Breast Cancer.
San Antonio Breast Cancer Symposium, 2012
Finn RS, Crown JP, Lang I, et al
Results of a randomized phase 2 study of PD 0332991, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with letrozole vs letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (BC).
ASCO Annual Meeting, 2011
Finn RS, Boer K, Lang I, et al
A randomized phase II study of PD 0332991, cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with letrozole for first-line treatment of patients with postmenopausal, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.
San Antonio Breast Cancer Symposium, 2011
Finn RS, Crown JP, Boer K, et al
Preliminary Results of a Randomized Phase 2 Study of PD 0332991, a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor, in Combination with Letrozole for First-Line Treatment of Patients (pts) with Post-Menopausal, ER+, HER2-Negative (HER2–) Advanced Breast Cancer.
ASCO Annual Meeting, 2010
Slamon DJ, Hurvitz SA, Applebaum S, et al
Phase I study of PD 0332991, cyclin-D kinase (CDK) 4/6 inhibitor in combination with letrozole for first-line treatment of patients with ER-positive, HER2-negative breast cancer.
Publications
Finn RS, Crown JP, Lang I, et al: The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol 16:25–35, 2015
Spera G, Fresco R, G Spera, et al: Beta Blockers and Improved Progression Free Survival in Patients with Advanced HER2 Negative Breast Cancer: a Retrospective Analysis of the ROSE/TRIO-012 Study. Ann Oncol mdx264.
Bell T, Crown J, Lang, I, et al: Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with ER +/HER2− advanced breast cancer as first-line treatment. Curr Med Res Opin 32; 959-965, 2016
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org