NCT01613482

TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

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

Interventions

Type	Name	Description
RADIATION	cerebral prophylactic radiation	24Gy, 12 fractions of 2 Gy
DRUG	Trastuzumab	Weekly, 2mg/kg of corporal weight
DRUG	Other chemotherapy in association with Trastuzumab	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

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-08-01
• Completion: 2012-01-01
• First posted: 2012-06-07
• Last updated: 2026-03-16

Locations

26 sites across 1 country: France