Breast Cancer Clinical Trial
— TSARINEOfficial title:
Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
Status | Terminated |
Enrollment | 13 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH) - Visceral metastasis, only or multiple - First line metastasis treatment by Trastuzumab in association with chemotherapy - Good general conditions: OMS=<2 or Karnofsky >=70% - Age > 18 years and < 70 years - Life expectancy >=3 mois - No Trastuzumab since more of 6 months - No cerebral metastasis (MRI) - Efficacy contraception for women with genital capacities - Consent signed by the patient Exclusion Criteria - Contraindication to IRM - Psychiatric decease - Prior cerebral radiotherapy, - Geographical constraint, compromising the fallow of patients - Infectious or other serious pathology, likely to stop the treatment - Positive serology (HIV, hBC, hBS) - Inclusion in an other clinical trial or in the 4 weeks before th inclusion - Pregnant or breastfeeding women |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre Paul Papin | Angers | |
France | Centre Hospitalier | BOULOGNE Sur Mer | |
France | Centre G-François Baclesse | Caen | |
France | Centre Maurice Tubiana | Caen | |
France | Centre Léonard de Vinci | Dechy | |
France | Centre Médical de Forcilles | Forcilles-attilly | |
France | Clinique des Ormeaux- Vauban | Le Havre | |
France | Centre Bourgogne | Lille | |
France | Centre Oscar LAMBRET | Lille | |
France | CHU Dupuytren | Limoges | |
France | Clinique Clinique Clementville | Montpellier | |
France | Centre Azuréen de Cancérologie | Mougins | |
France | Centre Hospitalier de Mulhouse | Mulhouse | |
France | Centre Catherine de Sienne | Nantes | |
France | Clinique Hartmann | NEUILLY sur SEINE | |
France | Centre Antoine Lacassagne | Nice | |
France | Centre médical Oncogard | Nîmes | |
France | Hôpital Tenon | Paris | |
France | Centre Catalan d'Oncologie | Perpignan | |
France | Centre Hospitalier LYON SUD | Pierre-benite | |
France | Centre René Huguenin | Saint Cloud | |
France | Centre Etienne DOLET | Saint Nazaire | |
France | Centre de Cancérologie Paris Nord | Sarcelles | |
France | Oncorad Garonne | Toulouse | |
France | Centre Alexis Vautrin | Vandoeuvre-les-nancy | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | free of cerebral metastasis survival | 5 years | No | |
Secondary | survival (overall and free visceral progression) | 5 years | Yes | |
Secondary | evaluate neurological, haemorrhagic, skin toxicities | weekly during radiotherapy and 2 weeks after radiotherapy | During study | Yes |
Secondary | neurological toxicities | neurological exams Cognitive test Subjective questionnaire of cognitive complaint questionnaire of EORTC QLQ-BN20 |
During study | Yes |
Secondary | P105 value | Blood sample | prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months | No |
Secondary | quality of life | Questionnaire QLQ-bn20 | before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | No |
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