NCT02089100

Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer

Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment. The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease. This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy
RADIATION	Systemic treatment

Timeline

• Start date: 2014-02-26
• Primary completion: 2033-10-01
• Completion: 2034-10-01
• First posted: 2014-03-17
• Last updated: 2026-03-19

Locations

18 sites across 1 country: France