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Completed

NCT Number: NCT01220076

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Léon Berard, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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:
  • Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
  • Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz
  • 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

Treatment and study plan

Tamoxifen

Drug

Primary outcomes

  1. Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer

    Time frame: 5 weeks

    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

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study 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+

Acronym: TAM

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2010
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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