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Studies & Results

TRIO 022

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

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

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.

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

For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org