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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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
Centre Léon Berard, Lyon, France
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
Primary outcomes
-
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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