TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

Breast Cancer Clinical Trial

— TSARINE  

Official title:

Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01613482
• Other study ID #: TSARINE 0602
• 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

• Breast Cancer
• Metastasis
• Sur-expressing Her2-neu

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