Studies & Results
TRIO022
A randomized, multicenter, doubleblind Phase 3 study of PD0332991 (Oral CDK 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with ER (+), HER2 (-) breast cancer who have not received any prior systemic anticancer treatment for advanced disease
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Presentations
ASCO Annual Meeting, 2013
Finn RS, Dieras V, Gelmon KA, et al
A randomized, multicenter, double-blind phase III study of palbociclib (PD-0332991), an oral CDK 4/6 inhibitor, plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with ER(+), HER2(–) breast cancer who have not received any prior systemic anticancer treatment for advanced disease.
ASCO 2016
Finn RS, et al.
PALOMA-2: Primary Results From a Phase 3 Trial of Palbociclib Plus Letrozole Compared With Placebo Plus Letrozole in Postmenopausal Women With ER+/HER2- Advanced Breast Cancer
SABCS 2016
Rugo HS, et al.
Palbociclib in combination with endocrine therapy in treatment-naive and previously treated elderly women with HR+, HER2– advanced breast cancer: a pooled analysis from randomized phase 2 and 3 studies
SABCS 2016
Diéras V, et al.
Long-term safety of palbociclib in combination with endocrine therapy in treatment-naive and previously treated women with HR+ HER2– advanced breast cancer: A pooled analysis from randomized phase 2 and 3 studies
ESMO Annual Meeting 2017
Finn RS, Gelmon KA, Ettl J, et al
Impact of Prior Treatment on Palbociclib Plus Letrozole Efficacy and Safety in Patients with Estrogen Receptor-Postivie/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) First-Line Advanced Breast Cancer: a PALOMA-2 Subgroup Analysis
SABCS 2017
Gelmon KA, et al.
Efficacy and safety of palbociclib (PAL) + letrozole (LET) as first-line therapy in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): Findings by geographic region from PALOMA-2
SABCS 2017
Harbeck N, et al.
Impact of palbociclib plus letrozole on patient-reported general health status compared with letrozole alone in ER+/HER2- advanced/metastatic breast cancer.
SABCS 2017
Rugo HS, et al.
Palbociclib (PAL) + letrozole (LET) as first-line therapy in estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC): Efficacy and safety updates with longer follow-up across patient subgroups.
SABCS 2017
Finn RS, et al.
Comprehensive gene expression biomarker analysis of CDK 4/6 and endocrine pathways from the PALOMA-2 study.
ASCO 2018
Finn RS, et al.
Treatment effect of palbociclib (PAL) plus endocrine therapy (ET) by prognostic and intrinsic subtype: A joint analysis of PALOMA2 and PALOMA3.
ASCO 2019
Iwata H, et al.
Association of drug-related polymorphisms with palbociclib-related neutropenia: Pharmacogenetic analysis of PALOMA-2/-3 (P2/3).
Publications
Wolff A C: CDK4 and CDK6 Inhibition in Breast Cancer — A New
Standard
N Engl J Med. 2016 Nov 17;375(20):1993-1994
Finn R, Martin M, Rugo H, et al: Palbociclib and Letrozole in Advanced Breast Cancer - A phase 2 study showed that progression-free survival was longer with palbociclib plus letrozole than with letrozole alone in the initial treatment of postmenopausal women with estrogen-receptor (ER) positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer. We performed a phase 3 study that was designed to confirm and expand the efficacy and safety data for palbociclib plus letrozole for this indication.
N Engl J Med 2016; 375:1925-1936
Kaplan R, Hass D, Warsh J.: Adding Value by Talking More.
N Engl J Med 2016; 375:1918-1920
Rugo HS, et al.:
Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial
Diéras V, et al.:
Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer.
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org
Presentations
ASCO Annual Meeting, 2013
Finn RS, Dieras V, Gelmon KA, et al
A randomized, multicenter, double-blind phase III study of palbociclib (PD-0332991), an oral CDK 4/6 inhibitor, plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with ER(+), HER2(–) breast cancer who have not received any prior systemic anticancer treatment for advanced disease.
ASCO 2016
Finn RS, et al.
PALOMA-2: Primary Results From a Phase 3 Trial of Palbociclib Plus Letrozole Compared With Placebo Plus Letrozole in Postmenopausal Women With ER+/HER2- Advanced Breast Cancer
SABCS 2016
Rugo HS, et al.
Palbociclib in combination with endocrine therapy in treatment-naive and previously treated elderly women with HR+, HER2– advanced breast cancer: a pooled analysis from randomized phase 2 and 3 studies
SABCS 2016
Diéras V, et al.
Long-term safety of palbociclib in combination with endocrine therapy in treatment-naive and previously treated women with HR+ HER2– advanced breast cancer: A pooled analysis from randomized phase 2 and 3 studies
ESMO Annual Meeting 2017
Finn RS, Gelmon KA, Ettl J, et al
Impact of Prior Treatment on Palbociclib Plus Letrozole Efficacy and Safety in Patients with Estrogen Receptor-Postivie/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) First-Line Advanced Breast Cancer: a PALOMA-2 Subgroup Analysis
SABCS 2017
Gelmon KA, et al.
Efficacy and safety of palbociclib (PAL) + letrozole (LET) as first-line therapy in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): Findings by geographic region from PALOMA-2
SABCS 2017
Harbeck N, et al.
Impact of palbociclib plus letrozole on patient-reported general health status compared with letrozole alone in ER+/HER2- advanced/metastatic breast cancer.
SABCS 2017
Rugo HS, et al.
Palbociclib (PAL) + letrozole (LET) as first-line therapy in estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC): Efficacy and safety updates with longer follow-up across patient subgroups.
SABCS 2017
Finn RS, et al.
Comprehensive gene expression biomarker analysis of CDK 4/6 and endocrine pathways from the PALOMA-2 study.
ASCO 2018
Finn RS, et al.
Treatment effect of palbociclib (PAL) plus endocrine therapy (ET) by prognostic and intrinsic subtype: A joint analysis of PALOMA2 and PALOMA3.
ASCO 2019
Iwata H, et al.
Association of drug-related polymorphisms with palbociclib-related neutropenia: Pharmacogenetic analysis of PALOMA-2/-3 (P2/3).
Publications
Wolff A C: CDK4 and CDK6 Inhibition in Breast Cancer — A New Standard N Engl J Med. 2016 Nov 17;375(20):1993-1994
Finn R, Martin M, Rugo H, et al: Palbociclib and Letrozole in Advanced Breast Cancer - A phase 2 study showed that progression-free survival was longer with palbociclib plus letrozole than with letrozole alone in the initial treatment of postmenopausal women with estrogen-receptor (ER) positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer. We performed a phase 3 study that was designed to confirm and expand the efficacy and safety data for palbociclib plus letrozole for this indication. N Engl J Med 2016; 375:1925-1936
Kaplan R, Hass D, Warsh J.: Adding Value by Talking More. N Engl J Med 2016; 375:1918-1920
Rugo HS, et al.: Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial
Diéras V, et al.: Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer.
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org