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

This study is currently recruiting participants.
Verified August 2016 by Institut Cancerologie de l'Ouest
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220076
First Posted: October 13, 2010
Last Update Posted: August 31, 2016
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.
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
  Purpose

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 Intervention Phase
Non Metastatic Breast Cancer Drug: tamoxifen Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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+

Resource links provided by NLM:


Further study details as provided by Institut Cancerologie de l'Ouest:

Primary Outcome Measures:
  • the phenotype of gene involved in the metabolism of tamoxifem will be analysed [ Time Frame: 5 weeks ]

Estimated Enrollment: 265
Study Start Date: September 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamoxifene Drug: tamoxifen

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220076


Contacts
Contact: PACTEAU Valérie valerie.pacteau@ico.unicancer.fr

Locations
France
Centre Léon Berard Recruiting
Lyon, France, 69000
Contact: Thomas Bachelot, Md    +33 478 78 28 28.      
Institut Curie Recruiting
Paris, France
Contact: Paul ¨Couttu, MD    +33 1 56 24 55 00      
Centre René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Mario Campone, MD    +33240679900      
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
  More Information

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT01220076     History of Changes
Other Study ID Numbers: BRD 08/11-A
First Submitted: October 11, 2010
First Posted: October 13, 2010
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Institut Cancerologie de l'Ouest:
Tamoxifen,
Breat Cancer
Pharmacogenetic
non metastatic breast cancer, HR +

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents