Breast Cancer, Metastasis, Sur-expressing Her2-neu
Conditions
Brief summary
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
Interventions
RADIATIONcerebral prophylactic radiation
24Gy, 12 fractions of 2 Gy
DRUGTrastuzumab
Weekly, 2mg/kg of corporal weight
DRUGOther chemotherapy in association with Trastuzumab
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
Sponsors
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| free of cerebral metastasis survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival (overall and free visceral progression) | 5 years | — |
| evaluate neurological, haemorrhagic, skin toxicities | During study | weekly during radiotherapy and 2 weeks after radiotherapy |
| neurological toxicities | During study | * neurological exams * Cognitive test * Subjective questionnaire of cognitive complaint * questionnaire of EORTC QLQ-BN20 |
| P105 value | prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months | Blood sample |
| quality of life | before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | Questionnaire QLQ-bn20 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORYazid BELKACEMI, MD
y-belkacemi@o-lambret.fr
Outcome results
None listed