TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

NCT01613482 | Terminated Phase 3

• 1 other identifier: TSARINE-0602
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

Breast Cancer; Metastasis; Sur-expressing Her2-neu

Outcome Measures

Primary Outcomes (1)

• free of cerebral metastasis survival

  5 years

Secondary Outcomes (5)

• survival (overall and free visceral progression)

  5 years

• evaluate neurological, haemorrhagic, skin toxicities

  During study

• neurological toxicities

  During study

• P105 value

  prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months

• quality of life

  before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Without cerebral prophylactic radiation

Drug: Trastuzumab; Drug: Other chemotherapy in association with Trastuzumab

Arm B

EXPERIMENTAL

With cerebral prophylactic radiation

Radiation: cerebral prophylactic radiation; Drug: Trastuzumab; Drug: Other chemotherapy in association with Trastuzumab

Interventions

cerebral prophylactic radiation RADIATION

24Gy, 12 fractions of 2 Gy

Arm B

Trastuzumab DRUG

Weekly, 2mg/kg of corporal weight

Also known as: Herceptin

Arm A; Arm B

Other chemotherapy in association with Trastuzumab DRUG

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (26)

Centre Paul Papin

Angers, 49933, France

Location

Centre Hospitalier

Boulogne-sur-Mer, 62200, France

Location

Centre Maurice Tubiana

Caen, 14052, France

Location

Centre G-François Baclesse

Caen, 14076, France

Location

Centre Léonard de Vinci

Dechy, 59187, France

Location

Centre Médical de Forcilles

Forcilles-attilly, 77150, France

Location

Clinique des Ormeaux- Vauban

Le Havre, 76600, France

Location

Centre Bourgogne

Lille, 59000, France

Location

Centre Oscar LAMBRET

Lille, 59020, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Clinique Clinique Clementville

Montpellier, 34000, France

Location

Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68100, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre médical Oncogard

Nîmes, 30907, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Centre Catalan d'Oncologie

Perpignan, 66000, France

Location

Centre Hospitalier LYON SUD

Pierre-Bénite, 69495, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Centre Etienne DOLET

Saint-Nazaire, 44600, France

Location

Centre de Cancérologie Paris Nord

Sarcelles, 95200, France

Location

Oncorad Garonne

Toulouse, 31400, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Trastuzumab; Association

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yazid BELKACEMI, MD

  y-belkacemi@o-lambret.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 7, 2012
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2012
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (26)