Individualized everolimus therapy in metastatic breast cancer
Key facts
- Where
- Budapest XII, MagyarországSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you already had any medicine for your cancer after it spread or became advanced?
- Have you been treated with a CDK4/6 inhibitor (for example palbociclib, ribociclib or abemaciclib)?
Where in Magyarország
- Orszagos Onkologiai IntezetBudapest XII, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orszagos Onkologiai Intezet
- Trial code
- EU 2023-505590-33-06
- Record updated
- 2025. március 19.
- Original description
Change in the quality of life in the two study arms, examined with the FACT-B quality of life testRead full original descriptionShow less
Change in the quality of life in the two study arms, examined with the FACT-B quality of life test
Inclusion: 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.
Exclusion: known allergy or hypersensitivity to everolimus, exemestane or their components; 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; Pregnancy or if the patient does not agree to use an appropriate non-hormonal method of contraception.