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TRIO-022

Closed

ANZ 1202/TRIO-022/A5481008

BCT Study Chair:

Janine Lombard

Letrozole is a standard treatment option for postmenopausal women with breast cancer that is hormone sensitive and has returned or spread to other areas of the body (advanced or metastatic breast cancer). The PALOMA-2 trial aims to determine if giving Letrozole together with a new drug, Palbociclib (PD-0332991, an oral CDK 4/6 inhibitor), is more effective than Letrozole alone.

international

646

INTERNATIONAL

Total number of trial

participants internationally

australia & new zealand

20

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

institutions

17

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

TRIO-022 PUBLICATIONS

2024

Overall survival with palbociclib plus letrozole in advanced breast cancer.

Slamon DJ, Diera V, Rugo HS, Harbeck N, Im S-A, Gelmon KA, Lipatov ON, Walshe JM, Martin M, Chavez-MacGregor M, Bananis E, Gauthier E, Lu DR, Kim S, Finn RS. Journal of Clinical Oncology. 2024; 42(9):994-1000, DOI https://doi.org/10.1200/JCO.23.00137, E-pub

2023

The real-world modeling of benefits demonstrated in major clinical trials on 2 HR+/HER2- metastatic breast cancer treatment with CDK4/6 inhibitor in the US: PALOMA-2 and MONALEESA-3.

Pilehvari A, Kimmick GG, You W, Bonilla G, Anderson RT. Journal of Clinical Oncology. 2023; 41(suppl 16):Abstract e13070, Abstract

2022

Prognostic and predictive role of RBsig and CCNE1/RB1 gene-expression signatures in patients with advanced breast cancer treated with palbociclib in combination with endocrine therapy in the PALOMA-2 and 3 trials.

Malorni L, Benelli M, Liu Y, Deng S, Zhang Z, Cuarducci C, Leo A, Nardone A, Galardi F, Risi E, Moretti E, Romagnoli D, Biagioni C, Paoli M, Biganzoli L, Migliaccio I. San Antonio Breast Cancer Symposium. 2022; Abstract# P5-05-17, Abstract

Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2- ABC): Analyses from PALOMA-2.

Finn SR, Rugo SH, Dieras CV, Harbeck N, Im AS, Gelmon AK, Walshe JM, Martin M, MacGregor CM, Bananis E, Gauthier RE, Lu RD, Kim S, Slamon JD. Journal of Clinical Oncology 2022; 40(16 suppl):ASCO Abstract #5LBA1003, Abstract

2019

Palbociclib plus letrozole as first-line therapy in estrogen receptor positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up.

Rugo HS, Finn RS, Dieras V, Ettl J, Lipatov O, Joy AA, Harbeck N, Castrellon A, Iyer S, Lu DR, Mori A, Gauther ER, Huang Bartlett C, Gelmon KA, Slamon DJ. Breast Cancer Research and Treatment 2019; 174(3):719-729, Journal

Association of drug-related polymorphisms with palbociclib-related neutropenia: Pharmacogenetic analysis of PALOMA-2/-3 (P2/3).

Iwata H, Fletcher O, Liu Y, Umeyama Y, Zhang Z, Schnell P, Marshall J-C, Johnson JG, Wood LS, Toi M, Finn RS, Cristofanilli M, Turner NC, Bartlett CH. Journal of Clinical Oncology. 2019; 37(suppl_15):Abstract 1060, Abstract

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