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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01220076
Other study ID # BRD 08/11-A
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date October 2016

Study information

Verified date March 2021
Source Institut Cancerologie de l'Ouest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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. - Lack of HER2 overexpression - Palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound - Patient scheduled to undergo breast cancer surgery - No metastases - Clinical Stage M0 - Performance index = 1 (OMS) - Neutrophils WBC > or = 1500 / mm3, Platelets > or = 100 000/mm3 Hemoglobin =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 / min) - 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: 1. Pregnant or Breastfeeding women 2. Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment 3. Consumption of grapefruit juice in the last 5 days of starting treatment 4. Congenital galactosemia 5. Glucose and galactose malabsorption 6. Lactase deficiency 7. Co-medications that may interfere with cytochrome P450: 8. Ongoing Enzyme inducers: - Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin - Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz 9. Ongoing Enzyme Inhibitors: - Inhibitors of serotonin reuptake: fluoxetine, paroxetine - Thioridazine. Quinidine - Amiodarone - Ca antagonists: diltiazem, verapamil - azole antifungals ketoconazole, fluconazole, miconazole. - No protease inhibitors: ritonavir, nelfinavir, amprenavir, indinavir. - Macrolides: erythromycin, clarithromycin, josamycin

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tamoxifen


Locations

Country Name City State
France Centre Léon Berard Lyon
France Institut Curie Paris
France Institut de Cancerologie de l'Ouest (ICO) Saint Herblain

Sponsors (1)

Lead Sponsor Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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