Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer (STEREO-SEIN)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Biopsy proven breast cancer stage IV AJCC TNM
- Age >18 years
- WHO status</=2
- Hormonal receptors positive breast cancer (IHC)
6. The primary tumor has to have been treated with curative intent (surgery and /or radiotherapy) 7. No prior treatment for metastatic relapse
It will be accpeted patients which would have begun a treatment in the case where:
- Hormonotherapy </= 1 month
Chemotherapy </= 1 cycle 8. a. Metastatic lesions out of previous radiation field 8. b. Equal or less than 5 metastatic lesions (measurable or not) 8. c. In case of measurable lesions, each </=10 cm or </=500 mL 9. For liver mets:
- adequate liver function (liver enzyme <3N, bilirubin<30mg/dl, albumin>2.5g/dl)
- no underlying cirrhosis or hepatitis
- liver metastase size </=7cm diameter
- not adjacent to stomach or small bowel 10. For abdominal mets:
- Adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min 11. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule 12. Life expectancy > 3 months 13. Affiliated to Health Insurance regimen 14. Written and signed consent form
Exclusion Criteria:
1. Triple negative breast cancer 3. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide) 4. Brain metastases 5. In spinal cord mets:
- More than 3 consecutive and contagious spinal segments involved by tumor
- Neurological examination prior randomization > 1 week
- Inability to tolerate treatment (unable to lie flat)
- Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
- Significant or progressive neurological deficit
- More than 25% spinal canal compromise
- Malignant epidural spinal cord compression or cauda equina syndrome
- Spine instability or neurological deficit resulting from bony compression of neural structures 6. Scleroderma or connective tissue disease as a contraindication to radiotherapy 7. Pregnancy or breast feeding period
Sites / Locations
- Gustave Roussy Cancer Campus Grand ParisRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
stereotactic body radiation therapy
no specific treatment
The SBRT of all metastases should start in maximum 4 weeks after randomization. Beginning of systemic treatment will take place before 2 and 7 days after SBRT completion. All metastases lesions should be treated every 48h.
no specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage)