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


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer, Metastasis, Sur-expressing Her2-neu

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

free of cerebral metastasis survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Yazid BELKACEMI, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

y-belkacemi@o-lambret.fr

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TSARINE 0602

NCT ID:

NCT01613482

Start Date:

October 2007

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • Metastasis
  • Sur-expressing Her2-neu
  • Breast Neoplasms
  • Neoplasm Metastasis

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