TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Treatments: Trastuzumab

Criteria

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