Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+"
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre René Gauducheau.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre René Gauducheau
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01220076
First received: October 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Metastatic Breast Cancer |
Drug: tamoxifen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Screening |
| 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+" |
Resource links provided by NLM:
Further study details as provided by Centre René Gauducheau:
Primary Outcome Measures:
- the phenotype of gene involved in the metabolism of tamoxifem will be analysed [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 265 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 immunostaining with an HR for Allred score> or = 3
- lack of HER2 overexpression
- palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound
- readily operable tumor
- No metastases
- Clinical Stage M0
- performance index ≤ 1 (OMS)
- Polynuclear > or = 1500 / mm3, Hb Platelets > or = 100 000/mm3 Hb ≥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
Exclusion Criteria:
- Alcohol Consumption
- Pregnancy, Breastfeeding
- Smoking
- 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
- malabsorption glucose and galactose
- lactase deficiency
- Co-medications that may interfere with cytochrome P450:
- enzyme inducers in progress:
- Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
- Antinfectieux: rifampin, rifabutin, névrirapine, griséofilvine, efavirenz
- Enzyme Inhibitors in progress:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220076
Locations
| France | |
| Centre Léon Berard | Recruiting |
| Lyon, France, 69000 | |
| Contact: Thomas Bachelot, Md +33 478 78 28 28. | |
| Institut Curie | Recruiting |
| Paris, France | |
| Contact: Paul ¨Couttu, MD +33 1 56 24 55 00 | |
| Centre René Gauducheau | Recruiting |
| Saint Herblain, France, 44805 | |
| Contact: Mario Campone, MD +33240679900 | |
Sponsors and Collaborators
Centre René Gauducheau
More Information
No publications provided
| Responsible Party: | Mme Scotet-Cérato, Centre René Gauducheau |
| ClinicalTrials.gov Identifier: | NCT01220076 History of Changes |
| Other Study ID Numbers: | BRD 08/11-A |
| Study First Received: | October 11, 2010 |
| Last Updated: | October 12, 2010 |
| Health Authority: | France : Afssaps |
Keywords provided by Centre René Gauducheau:
|
Tamoxifen, Breat Cancer Pharmacogenetic non metastatic breast cancer, HR + |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013