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

March 12, 2026 updated by: Centre Oscar Lambret

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Centre Paul Papin
      • Boulogne-sur-Mer, France, 62200
        • Centre hospitalier
      • Caen, France, 14052
        • Centre Maurice Tubiana
      • Caen, France, 14076
        • Centre G-François Baclesse
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Forcilles-attilly, France, 77150
        • Centre Médical de Forcilles
      • Le Havre, France, 76600
        • Clinique des Ormeaux- Vauban
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59000
        • Centre Bourgogne
      • Limoges, France, 87042
        • Chu Dupuytren
      • Montpellier, France, 34000
        • Clinique Clinique Clementville
      • Mougins, France, 06250
        • Centre Azuréen de Cancérologie
      • Mulhouse, France, 68100
        • Centre Hospitalier de Mulhouse
      • Nantes, France, 44202
        • Centre Catherine de Sienne
      • Neuilly-sur-Seine, France, 92200
        • Clinique Hartmann
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nîmes, France, 30907
        • Centre médical Oncogard
      • Paris, France, 75020
        • Hôpital Tenon
      • Perpignan, France, 66000
        • Centre Catalan d'Oncologie
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Saint-Cloud, France, 92210
        • Centre Rene Huguenin
      • Saint-Nazaire, France, 44600
        • Centre Etienne DOLET
      • Sarcelles, France, 95200
        • Centre de Cancerologie Paris Nord
      • Toulouse, France, 31400
        • Oncorad Garonne
      • Vandœuvre-lès-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Without cerebral prophylactic radiation
Drug: Trastuzumab
Weekly, 2mg/kg of corporal weight
Other Names:
  • Herceptin
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
Drug: Trastuzumab
Weekly, 2mg/kg of corporal weight
Other Names:
  • Herceptin
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
Radiation: cerebral prophylactic radiation
24Gy, 12 fractions of 2 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
free of cerebral metastasis survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival (overall and free visceral progression)
Time Frame: 5 years
5 years
evaluate neurological, haemorrhagic, skin toxicities
Time Frame: During study
weekly during radiotherapy and 2 weeks after radiotherapy
During study
neurological toxicities
Time Frame: During study
  • neurological exams
  • Cognitive test
  • Subjective questionnaire of cognitive complaint
  • questionnaire of EORTC QLQ-BN20
During study
P105 value
Time Frame: prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months
Blood sample
prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months
quality of life
Time Frame: before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Questionnaire QLQ-bn20
before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Yazid BELKACEMI, MD, y-belkacemi@o-lambret.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimated)

June 7, 2012

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSARINE-0602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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