Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

Ki vehet részt

• Histologically or cytological confirmed recurrent OMBC
• Age ≥18 years old
• OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT
• Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease
• Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment
• Patients with local recurrence and OMBC must have a controlled local recurrence
• ECOG/WHO 0-2
• Life expectancy > 6 months
• Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred)
• Symptomatic bone metastases are allowed if ablative therapy can be delivered
• Adequate organ function for the planned treatment according to local guide-lines
• 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
• For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of > 60mL/min
• 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
• Negative pregnancy test within 14 days prior to start of treatment*
• If childbearing potential, willing to use an effective form of contraception*
• 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
• Signed informed consent and willingness to follow the trial procedures

Ki nem vehet részt

• > 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included). Change due to toxicity allowed
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
• Malignant pleural effusion or ascites
• Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance
• Oligometastases in brain
• Metastasis growth that involves > 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit
• Unable to undergo imaging by either CT scan or MRI
• Pregnancy or breast-feeding