TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

Phase 3

Terminated

• Conditions: Breast Cancer; Metastasis; Sur-expressing Her2-neu
• Interventions: Radiation: cerebral prophylactic radiation; Drug: Other chemotherapy in association with Trastuzumab; Drug: Trastuzumab

• Registration Number: NCT01613482
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2012-06
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-06
• Last Update Submitted: 2012-06-06
• Study First Posted: 2012-06-07
• Last Update Posted: 2012-06-07
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Other chemotherapy in association with Trastuzumab	Without cerebral prophylactic radiation
Arm B	cerebral prophylactic radiation	With cerebral prophylactic radiation
Arm B	Other chemotherapy in association with Trastuzumab	With cerebral prophylactic radiation
Arm B	Trastuzumab	With cerebral prophylactic radiation
Arm A	Trastuzumab	Without cerebral prophylactic radiation

Primary Outcome Measures

Name	Time	Method
free of cerebral metastasis survival	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier; 🇫🇷 BOULOGNE Sur Mer, France

Centre Maurice Tubiana; 🇫🇷 Caen, France

Centre G-François Baclesse; 🇫🇷 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

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