Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
Study Details
Study Description
Brief Summary
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.
The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tamoxifene
|
Drug: tamoxifen
|
Outcome Measures
Primary Outcome Measures
- Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer [5 weeks]
The primary endpoint is the determination of the variation in the KI-67 expression, a marker of cell proliferation, at the tumour level between the initial biopsy (T0) and after 5 weeks of tamoxifen treatment, in relation to cytochrome 2D6 polymorphisms. A 50% geometric reduction in KI-67 expression at 5 to 7 weeks should be considered as a major response
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 immunohistochemistry.
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Lack of HER2 overexpression
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Palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound
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Patient scheduled to undergo breast cancer surgery
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No metastases
-
Clinical Stage M0
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Performance index ≤ 1 (OMS)
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Neutrophils WBC > or = 1500 / mm3, Platelets > or = 100 000/mm3 Hemoglobin ≥10 g/dL
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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).
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Normal renal function (creatinine ≤ 1.5 mg / dL or creatinine clearance ≥ 60 mL / min)
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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
Non-Inclusion Criteria:
-
Pregnant or Breastfeeding women
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Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment
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Consumption of grapefruit juice in the last 5 days of starting treatment
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Congenital galactosemia
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Glucose and galactose malabsorption
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Lactase deficiency
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Co-medications that may interfere with cytochrome P450:
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Ongoing Enzyme inducers:
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Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
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Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz
- Ongoing Enzyme Inhibitors:
-
Inhibitors of serotonin reuptake: fluoxetine, paroxetine
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Thioridazine. Quinidine
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Amiodarone
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Ca antagonists: diltiazem, verapamil
-
azole antifungals ketoconazole, fluconazole, miconazole.
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No protease inhibitors: ritonavir, nelfinavir, amprenavir, indinavir.
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Macrolides: erythromycin, clarithromycin, josamycin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Léon Berard | Lyon | France | 69000 | |
| 2 | Institut Curie | Paris | France | ||
| 3 | Institut de Cancerologie de l'Ouest (ICO) | Saint Herblain | France | 44805 |
Sponsors and Collaborators
- Institut Cancerologie de l'Ouest
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRD 08/11-A