Individualized everolimus therapy in metastatic breast cancer

Other illness

• known allergy or hypersensitivity to everolimus, exemestane or their components

Lab values

• Known significant cardiac disease: major arrhythmia or significant conduction disturbance (grade 2 or more in severity), infarction or unstable angina within 6 months, collapse of cardiac origin without appropriate therapy, long QT syndrome, heart failure
• any other serious acute or chronic condition (organic or psychiatric disease, laboratory abnormality, severe pulmonary disease) which, in the opinion of the treating physician, would result in an unacceptable increase in the risk of therapy

Other

• Pregnancy or if the patient does not agree to use an appropriate non-hormonal method of contraception.

• patient over 18 years of age
• histologically proven estrogen receptor positive and HER2 receptor negative invasive breast tumour
• Irresectable or metastatic disease
• satisfactory overall performance status: ECOG 0-1
• adequate organ function a. Neutrophil count ≥ 1.5 G/l, platelet count ≥ 100 G/l, haemoglobin ≥ 10 g/dl b. GOT/GPT less than 2.5 times the upper limit of the normal range (5 times in case of liver metastasis) c. bilirubin less than 1,5 times the upper limit of the normal range (except Gilbert's disease where less than 3 times) d. creatinine less than 1,5 times the upper limit of the normal range or eGFR higher than 60 ml/min
• at least one previous line of endocrine-based palliative therapy that included a CDK4/6 inhibitor.
• previous palliative chemotherapy is allowed.
• Postmenopausal female patient, or if premenopausal female or male patient, simultaneous use of GNRH analogue