TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention (TSARINE)

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01613482
First received: June 1, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Metastasis
Sur-expressing Her2-neu
Radiation: cerebral prophylactic radiation
Drug: Trastuzumab
Drug: Other chemotherapy in association with Trastuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • free of cerebral metastasis survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival (overall and free visceral progression) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • evaluate neurological, haemorrhagic, skin toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]
    weekly during radiotherapy and 2 weeks after radiotherapy

  • neurological toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]
    • neurological exams
    • Cognitive test
    • Subjective questionnaire of cognitive complaint
    • questionnaire of EORTC QLQ-BN20

  • P105 value [ Time Frame: prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months ] [ Designated as safety issue: No ]
    Blood sample

  • quality of life [ Time Frame: before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ] [ Designated as safety issue: No ]
    Questionnaire QLQ-bn20


Enrollment: 13
Study Start Date: October 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Without cerebral prophylactic radiation
Drug: Trastuzumab
Weekly, 2mg/kg of corporal weight
Drug: 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
Experimental: Arm B
With cerebral prophylactic radiation
Radiation: cerebral prophylactic radiation
24Gy, 12 fractions of 2 Gy
Drug: Trastuzumab
Weekly, 2mg/kg of corporal weight
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613482

Locations
France
Centre Paul Papin
Angers, France, 49933
Centre Hospitalier
BOULOGNE Sur Mer, France, 62200
Centre Maurice Tubiana
Caen, France, 14052
Centre G-François Baclesse
Caen, France, 14076
Centre Léonard de Vinci
Dechy, France, 59187
Centre Médical de Forcilles
Forcilles-attilly, France, 77150
Clinique des Ormeaux- Vauban
Le Havre, France, 76600
Centre Bourgogne
Lille, France, 59000
Centre Oscar LAMBRET
Lille, France, 59020
CHU Dupuytren
Limoges, France, 87042
Clinique Clinique Clementville
Montpellier, France, 34000
Centre Azuréen de Cancérologie
Mougins, France, 06250
Centre Hospitalier de Mulhouse
Mulhouse, France, 68100
Centre Catherine de Sienne
Nantes, France, 44202
Clinique Hartmann
NEUILLY sur SEINE, France, 92200
Centre Antoine Lacassagne
Nice, France, 06189
Centre médical Oncogard
Nîmes, France, 30907
Hôpital Tenon
Paris, France, 75020
Centre Catalan d'Oncologie
Perpignan, France, 66000
Centre Hospitalier LYON SUD
Pierre-benite, France, 69495
Centre René Huguenin
Saint Cloud, France, 92210
Centre Etienne DOLET
Saint Nazaire, France, 44600
Centre de Cancérologie Paris Nord
Sarcelles, France, 95200
Oncorad Garonne
Toulouse, France, 31400
Centre Alexis Vautrin
Vandoeuvre-les-nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Yazid BELKACEMI, MD y-belkacemi@o-lambret.fr
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01613482     History of Changes
Other Study ID Numbers: TSARINE 0602
Study First Received: June 1, 2012
Last Updated: June 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014