Treatment of Oligometastatic Breast Cancer - a Randomised Phase 3 Trial Comparing Stereotactic Ablative Radiotherapy and Systemic Treatment With Systemic Treatment Alone as 1st Line Treatment
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.
• 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.