Overview

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

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut Cancerologie de l'Ouest
Treatments:
Tamoxifen
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