Preventing alpelisib-related hyperglycaemia in HR+/HER2−/PIK3CA-mutated advanced breast cancer using metformin (METALLICA): a multicentre, open-label, single-arm, phase 2 trial

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). Between August 13th, 2020 and March 23rd, 2022,...

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Published in:EClinicalMedicine 2024-05, Vol.71, p.102520-102520, Article 102520
Main Authors: Llombart-Cussac, Antonio, Pérez-Garcia, José Manuel, Ruiz Borrego, Manuel, Tolosa, Pablo, Blanch, Salvador, Fernández-Ortega, Adela, Urruticoechea, Ander, Blancas, Isabel, Saura, Cristina, Rojas, Beatriz, Bermejo, Begoña, Ponce Lorenzo, José, Gion, María, Cortez-Castedo, Patricia, Llabres, Elisenda, Galve, Elena, Cueva, Juan Fernando, López, Ana, Alonso-Romero, José Luis, González-Santiago, Santiago, Martínez de Dueñas, Eduardo, Ciruelos, Eva, Martrat, Griselda, Gener, Petra, Alcalá-López, Daniel, Sampayo-Cordero, Miguel, Gómez-Peralta, Fernando, Cortés, Javier
Format: Article
Language:English
Subjects:
Alpelisib
HR+/HER2−/PIK3CA-mutated advanced breast cancer
Hyperglycaemia
Prophylactic metformin
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Summary: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). 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
ISSN:2589-5370
2589-5370
DOI:10.1016/j.eclinm.2024.102520