Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.

Summary

CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.

Timeline

Start

2017-07-13

Primary completion

2019-06-10

Completion

2019-07-20

Publications

• Villacampa G, Falato C, Pare L, Hernando C, Arumi M, Saura C, Gomez G, Munoz M, Gil-Gil M, Izarzugaza Y, Ferrer N, Najera-Zuloaga J, Montano A, Ciruelos E, Gonzalez-Santiago S, Villagrasa P, Gavila J, Prat A, Pascual T. Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial. Eur J Cancer. 2022 Oct;174:232-242. doi: 10.1016/j.ejca.2022.07.028. Epub 2022 Sep 5.
• Prat A, Saura C, Pascual T, Hernando C, Munoz M, Pare L, Gonzalez Farre B, Fernandez PL, Galvan P, Chic N, Gonzalez Farre X, Oliveira M, Gil-Gil M, Arumi M, Ferrer N, Montano A, Izarzugaza Y, Llombart-Cussac A, Bratos R, Gonzalez Santiago S, Martinez E, Hoyos S, Rojas B, Virizuela JA, Ortega V, Lopez R, Celiz P, Ciruelos E, Villagrasa P, Gavila J. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2020 Jan;21(1):33-43. doi: 10.1016/S1470-2045(19)30786-7. Epub 2019 Dec 11.

Drugs

Indications