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Terminated

NCT Number: NCT01613482

TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

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

Why the study stopped: Lack of enrollment
Terminated

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sur-expressing Her2-neu

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Paul Papin, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cerebral prophylactic radiation

Radiation

24Gy, 12 fractions of 2 Gy

Trastuzumab

Drug

Weekly, 2mg/kg of corporal weight

Other names: Herceptin

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

Primary outcomes

  1. free of cerebral metastasis survival

    Time frame: 5 years

Secondary outcomes

  1. survival (overall and free visceral progression)

    Time frame: 5 years

  2. evaluate neurological, haemorrhagic, skin toxicities

    Time frame: During study

    weekly during radiotherapy and 2 weeks after radiotherapy

  3. neurological toxicities

    Time frame: During study

    • neurological exams
    • Cognitive test
    • Subjective questionnaire of cognitive complaint
    • questionnaire of EORTC QLQ-BN20

  4. P105 value

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

    Blood sample

  5. quality of life

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

    Questionnaire QLQ-bn20

Interested in participating?

Terminated

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Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: TSARINE

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Jun 7, 2012
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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