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.
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. Patients with 1-5 metastases in 1-2 organs (confirmed by PET-CT) with any breast cancer subtype can be enrolled. All metastases must be available for SABR. The primary aim is to investigate if the addition of SABR to the oligometastatic sites in addition to the standard first-line treatment can improve progression-free survival (PFS). Secondary aims are to compare overall survival (OS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients). Exploratory analyses: Circulating tumour DNA as an early sign of disease progression. Immun panel for determination of the effect of SABR on patients´ immune response. To investigate the survival for each BC subtype (Luminal, HER2+ and TNBC). To investigate survival in patients with de novo OMBC and recurrent OMBC respectively. Stratifications are based on subtype (luminal, HER2-positive vs TNBC) and type of OMBC (de novo vs. recurrent) without formal sample size calculation for the stratification factor (exploratory analysis). Patients with de novo metastatic OMBC that is planned for neoadjuvant treatment are recommended to complete treatment followed by standard surgery and radiotherapy or SABR towards the primary tumour lesion(s).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
345
Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.
Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, Sweden
RECRUITINGProgression-free survival (PFS)
Time from the date of randomisation to the date of disease-progression at any site or death from any cause.
Time frame: 3 years after the last patient inclusion
Overall survival (OS)
Time from the date of randomisation to the date of death from any cause.
Time frame: 3 years after the last patient inclusion
Local Control Rate (LCR)
Time from the date of randomisation to the date of progress in previously treated metastases
Time frame: 3 years after the last patient inclusion
Safety analysis - acute toxicity
Reported according to CTCAE v.5.0
Time frame: From the first dose of SABR to 3 months after the last dose of SABR
Safety analysis - late toxicity
Reported according to CTCAE v.5.0
Time frame: From the first dose of SABR to 3 years after the last dose of SABR
Health-related quality of life Cancer-30
European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30)
Time frame: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.
Health-related quality of life Breast-23
European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23)
Time frame: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.
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