Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+"

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by Centre René Gauducheau.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Centre René Gauducheau

ClinicalTrials.gov Identifier:

NCT01220076

First received: October 11, 2010

Last updated: October 12, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 11, 2010
Last Updated Date	October 12, 2010
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2010)	the phenotype of gene involved in the metabolism of tamoxifem will be analysed [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01220076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+"
Official Title ^ICMJE	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+"
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Primary Purpose: Screening
Condition ^ICMJE	Non Metastatic Breast Cancer
Intervention ^ICMJE	Drug: tamoxifen
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	265
Completion Date	Not Provided
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 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 ultrasound 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 / 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 Exclusion Criteria: Alcohol Consumption Pregnancy, Breastfeeding Smoking 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 Amiodarone Ca antagonists: diltiazem, verapamil azole antifungals ketoconazole, fluconazole, miconazole. No protease inhibitors: ritonavir, nelfinavir, amprenavir, indinavir. Macrolides: erythromycin, clarithromycin, josamycin
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01220076
Other Study ID Numbers ^ICMJE	BRD 08/11-A
Has Data Monitoring Committee	No
Responsible Party	Mme Scotet-Cérato, Centre René Gauducheau
Study Sponsor ^ICMJE	Centre René Gauducheau
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre René Gauducheau
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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