TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

Study Overview
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Brief Summary
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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.

Official Title
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Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

Conditions
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Breast Cancer, Metastasis, Sur-expressing Her2-neu

Intervention / Treatment
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* Radiation: cerebral prophylactic radiation
* Drug: Trastuzumab
* Drug: Other chemotherapy in association with Trastuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Without cerebral prophylactic radiation | Drug: Trastuzumab<br>* Weekly, 2mg/kg of corporal weight<br>Drug: Other chemotherapy in association with Trastuzumab<br>* 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<br>|
| Experimental: Arm B<br>With cerebral prophylactic radiation | Radiation: cerebral prophylactic radiation<br>* 24Gy, 12 fractions of 2 Gy<br>Drug: Trastuzumab<br>* Weekly, 2mg/kg of corporal weight<br>Drug: Other chemotherapy in association with Trastuzumab<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free of cerebral metastasis survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| neurological toxicities | neurological exams Cognitive test Subjective questionnaire of cognitive complaint questionnaire of EORTC QLQ-BN20 | 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 |