Antonio Llombart-Cussac, José Manuel Pérez-Garcia, Manuel Ruiz Borrego, Pablo Tolosa, Salvador Blanch, Adela Fernández-Ortega, Ander Urruticoechea, Isabel Blancas, Cristina Saura, Beatriz Rojas, Begoña Bermejo, José Ponce Lorenzo, María Gion, Patricia Cortez-Castedo, Elisenda Llabres, Elena Galve, Juan Fernando Cueva, Ana López, José Luis Alonso-Romero, Santiago González-Santiago, Eduardo Martínez de Dueñas, Eva Ciruelos, Griselda Martrat, Petra Gener, Daniel Alcalá-López, Miguel Sampayo-Cordero, Fernando Gómez-Peralta, Javier Cortés
BACKGROUND: Hyperglycaemia is an early and frequent adverse event during alpelisib treatment. METALLICA aimed to evaluate prophylactic metformin to prevent or reduce hyperglycaemia occurrence in patients with HR+/HER2-/ PIK3CA -mutated advanced breast cancer (ABC). METHODS: Between August 13th, 2020 and March 23rd, 2022, this 2-cohort, phase 2, multicentre, single-arm trial (NCT04300790) enrolled patients with HR+/HER2-/PIK3CA-mutated ABC: cohort A, normal glycaemia (fasting plasma glucose <100 mg/dL [<5...
May 2024: EClinicalMedicine