TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention (NCT01613482) | Clinical Trial Compass
TerminatedPhase 3
TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
Stopped: Lack of enrollment
France13 participantsStarted 2008-01
Plain-language summary
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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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