Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

Inclusion Criteria

• •1. Histologically or cytological confirmed recurrent OMBC.
• •2. Age ≥18 years old.
• •3. OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
• •4. Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
• •5. Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.
• •6. Patients with local recurrence and OMBC must have a controlled local recurrence.
• •7. ECOG/WHO 0-2.
• •8. Life expectancy \> 6 months.
• •9. Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).
• •10. If measurable lesions, each ≤ 5 cm.
• •11. Symptomatic bone metastases are allowed if ablative therapy can be delivered (femoral metastasis not allowed).
• •12. Adequate organ function for the planned treatment according to local guide-lines.
• •13. For patients with liver metastasis:
• •* No cirrhosis or hepatitis
• •* Hepatic function:
• •* Total bilirubin level \< 3.0 x institutional ULN
• •* ALT, AST, GGT, and alkaline phosphatase levels \< 3.0 x institutional ULN
• •* Albumin \> 2.5 mg/dL
• •* Metastasis not adjutant to stomach or small bowel.
• •14. For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \> 60mL/min.
• •15. Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator.
• •16. Negative pregnancy test within 14 days prior to start of treatment\*.
• •17. If childbearing potential, willing to use an effective form of contraception\*.
• •18. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
• •19. Signed informed consent and willingness to follow the trial procedures.