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

NCT ID: NCT01220076

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-10-31

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.

Conditions

Non Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Tamoxifene

Group Type: EXPERIMENTAL

tamoxifen

Intervention Type: DRUG

Interventions

tamoxifen

Intervention Type: DRUG

Eligibility 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 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

1. Pregnant or Breastfeeding women

2. Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment

3. Consumption of grapefruit juice in the last 5 days of starting treatment

4. Congenital galactosemia

5. Glucose and galactose malabsorption

6. Lactase deficiency

7. Co-medications that may interfere with cytochrome P450:

8. Ongoing Enzyme inducers:

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

9. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Léon Berard

Lyon, , France

Institut Curie

Paris, , France

Institut de Cancerologie de l'Ouest (ICO)

Saint-Herblain, , France

Countries

France

Other Identifiers

BRD 08/11-A

Identifier Type: -

Identifier Source: org_study_id