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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01220076
Recruitment Status : Recruiting
First Posted : October 13, 2010
Last Update Posted : August 31, 2016
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

October 11, 2010
October 13, 2010
August 31, 2016
September 2009
September 2016   (Final data collection date for primary outcome measure)
the phenotype of gene involved in the metabolism of tamoxifem will be analysed [ Time Frame: 5 weeks ]
Same as current
Complete list of historical versions of study NCT01220076 on Archive Site
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Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
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+

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.

Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Non Metastatic Breast Cancer
Drug: tamoxifen
Experimental: Tamoxifene
Intervention: Drug: tamoxifen
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2016
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact: PACTEAU Valérie
BRD 08/11-A
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Institut Cancerologie de l'Ouest
Institut Cancerologie de l'Ouest
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Not Provided
Institut Cancerologie de l'Ouest
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP