Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+"
- Adult Females (≥ 18 years), with effective contraception. The contraceptive should
not use estrogen to a derivative. It must be continued during treatment with
tamoxifen for at least two months after his arrest.
- histologically confirmed diagnosis of invasive breast cancer, previously untreated.
Patients have been supported for a breast cancer may be included if a period of at
least 2 years between the last systemic treatment of inclusion in the study.
- Primary tumor hormonopositive: ER and / or PR ≥ 50% by immunostaining with an HR for
Allred score> or = 3
- lack of HER2 overexpression
- palpable primary tumor or greater than or equal to 20 mm in diameter, measured by
- readily operable tumor
- No metastases
- Clinical Stage M0
- performance index ≤ 1 (OMS)
- Polynuclear > or = 1500 / mm3, Hb Platelets > or = 100 000/mm3 Hb ≥10 g/dL
- normal liver function: bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases).
- Normal renal function (creatinine ≤ 1.5 mg / dL or creatinine clearance ≥ 60 mL /
- cardiac function (MUGA scan or ultrasound February> 55%) and lung function, 5.2.2
Criteria related to participation in the study:
- Patient affiliated to social security, Patient has signed and dated consent
- Alcohol Consumption
- Pregnancy, Breastfeeding
- Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment
- Consumption of grapefruit juice in the last 5 days of starting treatment
- congenital galactosemia
- malabsorption glucose and galactose
- lactase deficiency
- Co-medications that may interfere with cytochrome P450:
- enzyme inducers in progress:
- Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
- Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz
- Enzyme Inhibitors in progress:
- Inhibitors of serotonin reuptake: fluoxetine, paroxetine
- Thioridazine. Quinidine
- Ca antagonists: diltiazem, verapamil
- azole antifungals ketoconazole, fluconazole, miconazole. No protease inhibitors:
ritonavir, nelfinavir, amprenavir, indinavir.
- Macrolides: erythromycin, clarithromycin, josamycin