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Postmenopausal women able to comply with the protocol requirements with metastatic breast cancerwhose tumors are estrogenERand/or progesteronePgRpositivedefined by core biopsy immunohistochemistry with greater than 10positive malignant epithelial cellsPatients must have documented expression of either PDGFR or CD117c-kitby immunohistochemistryPatients may have received tamoxifen in the adjuvant/neoadjuvant or settingPatients may have previously received chemotherapy in the adjuvantneoadjuvant settingthough this is not requiredPrior chemotherapy for metastatic breast cancer is allowedConcomitant bisphosphonates are allowed for patients with bone metastases and who have another site of measurable diseasePost menopausal status defined by one of the followingno spontaneous menses for at least 1 yearin women greater than or equal to 55 years spontaneous menses within the past 1 year in women greater than or equal to 55 years with postmenopausal gonadotrophin levelsLH and FSH levels greater than 40 IU/Lor postmenopausal estradiol levelsless than 5mg/dlor according to the definition ofpostmenopausal rangefor the laboratory involved bilateral oophorectomyPerformance statusECOG greater than or equal to 2Patients must have measurable diseasedefined as at least one lesion that can be accurately measured in at least one dimensionlongest diameter to be recordedas greater than or equal to 10 mm with conventional techniquesBone disease only will not be accepted as measurable diseasePleural or peritoneal effusions will not be accepted as measurable diseaseAdequate bone marrow functionANC1.5 x 10 to the 9th power/L and platelets greater than or equal to 100.0 x10 to the 9th power/Land hemoglobin greater than 10.0 g/dLAdequate renal functioncreatinine less than 1.5 mg/dland hepatic functionTBilirubin less than 1.5 x normalAST less than 2.5 x normalA life expectancy of at least 6 monthsLocalized radiotherapywhich does not influence the signal of evaluable lesionis allowed prior to the initiation of Imatinib MesylatePatients must have recovered from the myelosuppressive effects of previous radiotherapyat least 2-4 weeksAbility to understand and the willingness to sign a written informed consent.
The CHMPin light of the data submitted and the scientific discussion within the Committeewas of the opinion that the SmPCslabelling and package leaflets should be harmonised across the EU.
Aromatase is an enzyme that works to help produce the hormone estrogenSome cancers use estrogen to growBy inhibiting aromatasethese estrogen driven cancer cells may stop growing.
Letrozole comes in tablet form and is taken by mouth once dailyLetrozole can be taken with or without foodIf you miss a dosetake it as soon as you rememberIf it is almost time for your next doseskip the missed doseDo not take two doses at the same timeDo not stop taking letrozole without talking to your healthcare team.
Letrozole is a drug used as hormone therapy for the treatment of breast cancerand included in a group of drugs called aromatase inhibitors due to its mechanism of actionEstrogen and progesterone are female sex hormones that promote cancer growthWhile in menstruating womenthese hormones are produced in the ovariesin menopausal womenit is produced in the fat tissue through a process known as aromataseThereforeletrozole interferes with this process in order to decrease the levels of estrogen in the body andconsequentlystop or slow down cancer growthor decrease the probability of cancer recurrence after surgeryLetrozole is only effective in hormone sensitive or hormone receptor positive breast cancer and its use is limited to women after menopause.
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