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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+

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01220076
Acronym
TAM
Enrollment
140
Registered
2010-10-13
Start date
2009-09-30
Completion date
2016-10-31
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Metastatic Breast Cancer

Keywords

Tamoxifen,, Breat Cancer, Pharmacogenetic, non metastatic breast cancer, HR +

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.

Interventions

DRUGtamoxifen

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer5 weeksThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026