Clinical trial NCT00171808 (phase 2, status: completed)
Conditions: endometrial cancer
ICD codes: N85.00, N85.01, N85.02, N99.85
Drugs: letrozole
SMILES: N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Age > 18 years

          -  Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the
             endometrium

          -  Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with
             surgery and/or radiation therapy

          -  Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is
             defined according to routine practice at each participating laboratory.

          -  Patient must be postmenopausal defined as

               -  Age ≥55 years.

               -  Age <55 but no spontaneous menses for at least 1 year.

               -  Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic
                  (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal
                  gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels
                  >40 IU/L) or postmenopausal estradiol levels (<5 ng/dL) or according to the
                  definition of "postmenopausal range" for the laboratory involved.

               -  Bilateral oophorectomy

               -  Radiation menopause

          -  Presence of measurable disease (by clinical/radiological examination - according to
             RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in
             which case > 10 mm)

          -  ECOG performance status of 0, 1 or 2

          -  Adequate bone marrow function (WBC ≥ 3.5 x 1'000'000'000/L and platelets ≥ 100.0 x
             1'000'000'000/L) and hemoglobin > 10.0 g/dl

          -  Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin < 25
             µmol/L, AST (SGOT < 60 U/L)

          -  Minimum life expectancy of at least 6 months

          -  Patients who are accessible for treatment and follow-up

        Exclusion Criteria:

          -  Presence of non-measurable disease only

          -  Other concomitant anti-cancer treatment (except external radiation treatment [XRT] for
             symptomatic metastatic lesions if other assessable untreated lesions are present)

          -  Prior treatment with aromatase inhibitors or anti-estrogens (up to one previous
             progestational hormone therapy regimen for recurrent disease is permitted)

          -  Clear cell or papillary serous histology, uterine sarcomas, mixed Mullerian tumors
             (MMT) and/or adenosarcomas

          -  Other concurrent malignant disease with the exception of cone-biopsied in situ
             carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma
             of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma
             (NHL), provided 5 years have elapsed from completion of therapy, and there has been no
             recurrence

          -  Known central nervous system (CNS) metastases, bilateral diffuse lymphangiosis
             carcinoma of the lung (>50 % of lung involvement, or dyspnea at rest requiring
             supplemental oxygen therapy), evidence of metastases estimated as more than a third of
             the liver as defined by sonogram and/or CT scan

          -  Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or
             hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated)

          -  Unstable angina and uncontrolled cardiac disease

          -  Treatment with other investigational drugs (drugs not marketed for any indication)
             within the past 30 days and/or the concomitant use of investigational drugs

          -  A history of non-compliance to medical regimens and patients who, in the opinion of
             the investigator, are unlikely to cooperate fully during the study

          -  Inability to swallow pills

        Additional protocol-defined inclusion/exclusion criteria may apply.