Status:
COMPLETED
Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Non Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 relationsh...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01220076
Start Date
September 1 2009
End Date
October 1 2016
Last Update
March 12 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Léon Berard
Lyon, France, 69000
2
Institut Curie
Paris, France
3
Institut de Cancerologie de l'Ouest (ICO)
Saint-Herblain, France, 44805