FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole

Exclusion Criteria

• •9. ER-positive and/or PgR-positive tumors, defined according to immunohistochemistry (i.e. \> 10% of positive cells after immunostaining), if woman younger 70 years; ER-positive or PgR-positive tumors if woman older than 70 years.
• •10. Fixed and frozen samples from the primary tumor, obtained before treatment, must be available for evaluation of biological markers (cDNA microarrays, EGFR, HER-2, intra-tumoral aromatase).
• •11. No concurrent second malignancy, including contralateral breast cancer (exceptions are: adequately treated basal cell carcinoma of the skin and in situ carcinoma of the cervix). Any prior second malignancy must be in remission for ³ 5 years.
• •12. No other serious illness or medical condition including:
• •* History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (\< 6 months) transmural infarction on ECG; poorly controlled hypertension (e.g. systolic \>180 mm Hg or diastolic greater than 100 mm Hg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias.
• •* Chronic lung disease
• •* History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia.
• •* Active concurrent infection
• •13. No concurrent or previous anti-cancer treatment is allowed
• •14. Adequate organ function as defined by:
• •* Neutrophils ³ 1.5 x 109/L
• •* Platelets ³ 100 x 109/L
• •* Bilirubin £ 1.5x upper limit of normal (ULN)
• •* Transaminases £ 2.5x ULN
• •* Creatinine £ 1.5x ULN
• •15. Normal left ventricular ejection fraction by echocardiography or MUGA scan \[for combination studies only\]
• •16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• •17. Before patient registration/randomization, informed consent must be given according to ICH/EU GCP, and national/local regulations.
• •Exclusion crieria :
• •Non specified