Clinical trial · Interventional
TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
NCT01613482CI-TRIAL-00105646TSARINEterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Sur-expressing Her2-neu | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cerebral prophylactic radiation | Radiation | — | UNRESOLVED |
| Other chemotherapy in association with Trastuzumab | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Without cerebral prophylactic radiation
- interventionNames
- Drug: Trastuzumab
- Drug: Other chemotherapy in association with Trastuzumab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- With cerebral prophylactic radiation
- interventionNames
- Radiation: cerebral prophylactic radiation
- Drug: Trastuzumab
- Drug: Other chemotherapy in association with Trastuzumab
Primary outcomes (1)
- measure
- free of cerebral metastasis survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.