TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01613482
• Date of registration: 01/06/2012
• Prospective Registration: No
• Primary sponsor: Centre Oscar Lambret
• Public title: TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention TSARINE
• Scientific title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
• Date of first enrolment: October 2007
• Target sample size: 13
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01613482
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Yazid BELKACEMI, MD
• Affiliation: [e-mail]

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Sur-expressing Her2-neu

Breast Cancer

Metastasis

Intervention(s)

Drug: Other chemotherapy in association with Trastuzumab

Drug: Trastuzumab

Radiation: cerebral prophylactic radiation

Primary Outcome(s)

free of cerebral metastasis survival [Time Frame: 5 years]

Secondary Outcome(s)

neurological toxicities [Time Frame: During study]

survival (overall and free visceral progression) [Time Frame: 5 years]

quality of life [Time Frame: before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months]

evaluate neurological, haemorrhagic, skin toxicities [Time Frame: During study]

P105 value [Time Frame: prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months]

Secondary ID(s)

TSARINE 0602

Source(s) of Monetary Support

Please refer to primary and secondary sponsors