Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+ (TAM)
Primary Purpose
Non Metastatic Breast Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
tamoxifen
Sponsored by

About this trial
This is an interventional screening trial for Non Metastatic Breast Cancer focused on measuring Tamoxifen,, Breat Cancer, Pharmacogenetic, non metastatic breast cancer, HR +
Eligibility 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:
- 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
Sites / Locations
- Centre Léon Berard
- Institut Curie
- Institut de Cancerologie de l'Ouest (ICO)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tamoxifene
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01220076
First Posted
October 11, 2010
Last Updated
March 10, 2021
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT01220076
Brief Title
Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
Acronym
TAM
Official 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+
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Metastatic Breast Cancer
Keywords
Tamoxifen,, Breat Cancer, Pharmacogenetic, non metastatic breast cancer, HR +
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamoxifene
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Primary Outcome Measure Information:
Title
Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer
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
Time Frame
5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Facility Information:
Facility Name
Centre Léon Berard
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Institut de Cancerologie de l'Ouest (ICO)
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
12. IPD Sharing Statement
Learn more about this trial
Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+
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