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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifene | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamoxifen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer | 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 | 5 weeks |
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Inclusion Criteria:
Non-Inclusion Criteria:
Pregnant or Breastfeeding women
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
Glucose and galactose malabsorption
Lactase deficiency
Co-medications that may interfere with cytochrome P450:
Ongoing Enzyme inducers:
Ongoing Enzyme Inhibitors:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Berard | Lyon | 69000 | France | |||
| Institut Curie |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Paris |
| France |
| Institut de Cancerologie de l'Ouest (ICO) | Saint-Herblain | 44805 | France |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |