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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01613482
Other study ID # TSARINE 0602
Secondary ID
Status Terminated
Phase Phase 3
First received June 1, 2012
Last updated June 6, 2012
Start date October 2007
Est. completion date October 2012

Study information

Verified date June 2012
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
cerebral prophylactic radiation
24Gy, 12 fractions of 2 Gy
Drug:
Trastuzumab
Weekly, 2mg/kg of corporal weight
Other 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

Locations

Country Name City State
France Centre Paul Papin Angers
France Centre Hospitalier BOULOGNE Sur Mer
France Centre G-François Baclesse Caen
France Centre Maurice Tubiana Caen
France Centre Léonard de Vinci Dechy
France Centre Médical de Forcilles Forcilles-attilly
France Clinique des Ormeaux- Vauban Le Havre
France Centre Bourgogne Lille
France Centre Oscar LAMBRET Lille
France CHU Dupuytren Limoges
France Clinique Clinique Clementville Montpellier
France Centre Azuréen de Cancérologie Mougins
France Centre Hospitalier de Mulhouse Mulhouse
France Centre Catherine de Sienne Nantes
France Clinique Hartmann NEUILLY sur SEINE
France Centre Antoine Lacassagne Nice
France Centre médical Oncogard Nîmes
France Hôpital Tenon Paris
France Centre Catalan d'Oncologie Perpignan
France Centre Hospitalier LYON SUD Pierre-benite
France Centre René Huguenin Saint Cloud
France Centre Etienne DOLET Saint Nazaire
France Centre de Cancérologie Paris Nord Sarcelles
France Oncorad Garonne Toulouse
France Centre Alexis Vautrin Vandoeuvre-les-nancy
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary free of cerebral metastasis survival 5 years No
Secondary survival (overall and free visceral progression) 5 years Yes
Secondary evaluate neurological, haemorrhagic, skin toxicities weekly during radiotherapy and 2 weeks after radiotherapy During study Yes
Secondary neurological toxicities neurological exams
Cognitive test
Subjective questionnaire of cognitive complaint
questionnaire of EORTC QLQ-BN20
During study Yes
Secondary P105 value Blood sample prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months No
Secondary quality of life Questionnaire QLQ-bn20 before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months No
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