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

Primary Purpose

Breast Cancer, Metastasis, Sur-expressing Her2-neu

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cerebral prophylactic radiation
Trastuzumab
Other chemotherapy in association with Trastuzumab
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier
  • Centre Maurice Tubiana
  • Centre G-François Baclesse
  • Centre Léonard de Vinci
  • Centre Médical de Forcilles
  • Clinique des Ormeaux- Vauban
  • Centre Bourgogne
  • Centre Oscar LAMBRET
  • CHU Dupuytren
  • Clinique Clinique Clementville
  • Centre Azuréen de Cancérologie
  • Centre Hospitalier de Mulhouse
  • Centre Catherine de Sienne
  • Clinique Hartmann
  • Centre Antoine Lacassagne
  • Centre médical Oncogard
  • Hôpital Tenon
  • Centre Catalan d'Oncologie
  • Centre Hospitalier LYON SUD
  • Centre René Huguenin
  • Centre Etienne DOLET
  • Centre de Cancérologie Paris Nord
  • Oncorad Garonne
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Without cerebral prophylactic radiation

With cerebral prophylactic radiation

Outcomes

Primary Outcome Measures

free of cerebral metastasis survival

Secondary Outcome Measures

survival (overall and free visceral progression)
evaluate neurological, haemorrhagic, skin toxicities
weekly during radiotherapy and 2 weeks after radiotherapy
neurological toxicities
neurological exams Cognitive test Subjective questionnaire of cognitive complaint questionnaire of EORTC QLQ-BN20
P105 value
Blood sample
quality of life
Questionnaire QLQ-bn20

Full Information

First Posted
June 1, 2012
Last Updated
June 6, 2012
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT01613482
Brief Title
TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
Acronym
TSARINE
Official Title
Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastasis, Sur-expressing Her2-neu

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Without cerebral prophylactic radiation
Arm Title
Arm B
Arm Type
Experimental
Arm Description
With cerebral prophylactic radiation
Intervention Type
Radiation
Intervention Name(s)
cerebral prophylactic radiation
Intervention Description
24Gy, 12 fractions of 2 Gy
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Weekly, 2mg/kg of corporal weight
Intervention Type
Drug
Intervention Name(s)
Other chemotherapy in association with Trastuzumab
Intervention Description
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
Primary Outcome Measure Information:
Title
free of cerebral metastasis survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
survival (overall and free visceral progression)
Time Frame
5 years
Title
evaluate neurological, haemorrhagic, skin toxicities
Description
weekly during radiotherapy and 2 weeks after radiotherapy
Time Frame
During study
Title
neurological toxicities
Description
neurological exams Cognitive test Subjective questionnaire of cognitive complaint questionnaire of EORTC QLQ-BN20
Time Frame
During study
Title
P105 value
Description
Blood sample
Time Frame
prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months
Title
quality of life
Description
Questionnaire QLQ-bn20
Time Frame
before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yazid BELKACEMI, MD
Organizational Affiliation
y-belkacemi@o-lambret.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier
City
BOULOGNE Sur Mer
ZIP/Postal Code
62200
Country
France
Facility Name
Centre Maurice Tubiana
City
Caen
ZIP/Postal Code
14052
Country
France
Facility Name
Centre G-François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Léonard de Vinci
City
Dechy
ZIP/Postal Code
59187
Country
France
Facility Name
Centre Médical de Forcilles
City
Forcilles-attilly
ZIP/Postal Code
77150
Country
France
Facility Name
Clinique des Ormeaux- Vauban
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Centre Bourgogne
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Oscar LAMBRET
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Clinique Clinique Clementville
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Centre Azuréen de Cancérologie
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Clinique Hartmann
City
NEUILLY sur SEINE
ZIP/Postal Code
92200
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Centre médical Oncogard
City
Nîmes
ZIP/Postal Code
30907
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Catalan d'Oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Centre Hospitalier LYON SUD
City
Pierre-benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Centre Etienne DOLET
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Centre de Cancérologie Paris Nord
City
Sarcelles
ZIP/Postal Code
95200
Country
France
Facility Name
Oncorad Garonne
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

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