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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT01220076
• Date of registration: 11/10/2010
• Prospective Registration: No
• Primary sponsor: Institut Cancerologie de l'Ouest
• Public title: Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+ TAM
• Scientific 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+
• Date of first enrolment: September 2009
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01220076
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Non Metastatic Breast Cancer

Intervention(s)

Drug: tamoxifen

Primary Outcome(s)

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]

Secondary ID(s)

BRD 08/11-A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors