Clinical trial · Interventional
Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
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+
NCT01220076CI-TRIAL-00050636TAMcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tamoxifene
- interventionNames
- Drug: tamoxifen
Primary outcomes (1)
- measure
- Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
- timeFrame
- 5 weeks
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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: 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
References
Publications (0)
Data not yet available
No reference posted for this study.