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Lack of enrollment
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Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Without cerebral prophylactic radiation |
|
| Arm B | Experimental | With cerebral prophylactic radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cerebral prophylactic radiation | Radiation | 24Gy, 12 fractions of 2 Gy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| free of cerebral metastasis survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| survival (overall and free visceral progression) | 5 years | |
| evaluate neurological, haemorrhagic, skin toxicities | weekly during radiotherapy and 2 weeks after radiotherapy | During study |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yazid BELKACEMI, MD | y-belkacemi@o-lambret.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49933 | France | |||
| Centre Hospitalier |
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| Trastuzumab |
| Drug |
Weekly, 2mg/kg of corporal weight |
|
|
| Other chemotherapy in association with Trastuzumab | Drug | other chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session |
|
| neurological toxicities |
| During study |
| P105 value | Blood sample | prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months |
| quality of life | Questionnaire QLQ-bn20 | before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Boulogne-sur-Mer |
| 62200 |
| France |
| Centre Maurice Tubiana | Caen | 14052 | France |
| Centre G-François Baclesse | Caen | 14076 | France |
| Centre Léonard de Vinci | Dechy | 59187 | France |
| Centre Médical de Forcilles | Forcilles-attilly | 77150 | France |
| Clinique des Ormeaux- Vauban | Le Havre | 76600 | France |
| Centre Bourgogne | Lille | 59000 | France |
| Centre Oscar LAMBRET | Lille | 59020 | France |
| CHU Dupuytren | Limoges | 87042 | France |
| Clinique Clinique Clementville | Montpellier | 34000 | France |
| Centre Azuréen de Cancérologie | Mougins | 06250 | France |
| Centre Hospitalier de Mulhouse | Mulhouse | 68100 | France |
| Centre Catherine de Sienne | Nantes | 44202 | France |
| Clinique Hartmann | Neuilly-sur-Seine | 92200 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Centre médical Oncogard | Nîmes | 30907 | France |
| Hôpital Tenon | Paris | 75020 | France |
| Centre Catalan d'Oncologie | Perpignan | 66000 | France |
| Centre Hospitalier LYON SUD | Pierre-Bénite | 69495 | France |
| Centre René Huguenin | Saint-Cloud | 92210 | France |
| Centre Etienne DOLET | Saint-Nazaire | 44600 | France |
| Centre de Cancérologie Paris Nord | Sarcelles | 95200 | France |
| Oncorad Garonne | Toulouse | 31400 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D001244 | Association |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013811 | Psychotherapeutic Processes |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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