Clinical trial NCT01613482: TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
Official title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Metastasis
Sur-expressing Her2-neu
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: free of cerebral metastasis survival
timeFrame: 5 years
Secondary outcomes:
measure: survival (overall and free visceral progression)
timeFrame: 5 years
measure: evaluate neurological, haemorrhagic, skin toxicities
timeFrame: During study
measure: neurological toxicities
timeFrame: During study
measure: P105 value
timeFrame: prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months
measure: quality of life
timeFrame: before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: BOULOGNE Sur Mer
country: France
facility: Centre Hospitalier
city: Caen
country: France
facility: Centre Maurice Tubiana
city: Caen
country: France
facility: Centre G-François Baclesse
city: Dechy
country: France
facility: Centre Léonard de Vinci
city: Forcilles-attilly
country: France
facility: Centre Médical de Forcilles
city: Le Havre
country: France
facility: Clinique des Ormeaux- Vauban
city: Lille
country: France
facility: Centre Bourgogne
city: Lille
country: France
facility: Centre Oscar LAMBRET
city: Limoges
country: France
facility: CHU Dupuytren
city: Montpellier
country: France
facility: Clinique Clinique Clementville
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: NEUILLY sur SEINE
country: France
facility: Clinique Hartmann
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: Centre médical Oncogard
city: Paris
country: France
facility: Hôpital Tenon
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Pierre-benite
country: France
facility: Centre Hospitalier LYON SUD
city: Saint Cloud
country: France
facility: Centre René Huguenin
city: Saint Nazaire
country: France
facility: Centre Etienne DOLET
city: Sarcelles
country: France
facility: Centre de Cancérologie Paris Nord
city: Toulouse
country: France
facility: Oncorad Garonne
city: Vandoeuvre-les-nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: y-belkacemi@o-lambret.fr
name: Yazid BELKACEMI, MD
role: PRINCIPAL_INVESTIGATOR
References: