LEA, trial summary    PDF trial summary

A randomised clinical trial investigating the effect of bevacizumab + endocrine therapy versus endocrine therapy in first-line therapy in postmenopausal patients with human epidermal growth factor receptor 2 (HER2) -negative and hormone receptor-positive advanced breast cancer

        Z

J Clin Oncol 2015;33:1045-52  



Studied treatment bevacizumab + letrozole/fulvestrant
Control treatment letrozole or fulvestrant



Patients first-line therapy in postmenopausal patients with human epidermal growth factor receptor 2 (HER2) -negative and hormone receptor-positive advanced breast cancer
Group sizes-9 / -9



Blindness Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI objective response - -9 - -9 no data progression-free survival (PFS) - -9 - -9 no data overall survival (OS) - -9 - -9 no data treatment-related deaths - -9 - -9 no data hypertension (grade 3) - -9 - -9 no data arterial thromboembolic event - -9 - -9 no data gastrointestinal perforation (grade 3) - -9 - -9 no data left ventricular systolic dysfunction (grade 2 or 3) - -9 - -9 no data high-grade congestive heart failure - -9 - -9 no data serious adverse events - -9 - -9 no data arterial/venous thromboembolism (grade 3) - -9 - -9 no data pulmonary embolism (grade 3) - -9 - -9 no data bleeding (grade 3) - -9 - -9 no data cardiomyopathy (grade 3) - -9 - -9 no data permanent discontinuation - -9 - -9 no data adverse events grade 3 - -9 - -9 no data venous thromboembolic event (grade 3) - -9 - -9 no data proteinuria (grade 3) - -9 - -9 no data wound-healing complications (grade 3) - -9 - -9 no data0,22,01,0

Martín M, Loibl S, von Minckwitz G, Morales S, Martinez N, Guerrero A, Anton A, Aktas B, Schoenegg W, Muñoz M, Garcia-Saenz JÁ, Gil M, Ramos M, Margeli M, Carrasco E, Liedtke C, Wachsmann G, Mehta K, De la Haba-Rodriguez JR Phase III trial evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for advanced breast cancer: the letrozole/fulvestrant and avastin (LEA) study. J Clin Oncol 2015;33:1045-52     [PMID: 25691671]   link to pdf   add to Mendeley  



Registering number (see trial on clinicaltrials.gov)
Code Name