Treatment of oligometastatic breast cancer – a randomized Phase 3 study comparing stereotactic ablative radiotherapy combined with systemic treatment versus systemic treatment alone as first-line treatment
We will compare the effectiveness of systemic treatment for breast cancer with the effectiveness of highly precise radiotherapy combined with systemic treatment.
Additional treatment of breast cancer with stereotactic ablative radiotherapy (SABR) may be more effective than systemic treatment alone and may not cause serious side effects; however, this has not yet been proven in patients with a small number of metastases. The information obtained from this study will help increase knowledge about the treatment of your type of breast cancer with stereotactic radiotherapy. The results of this study may help improve understanding of the disease and improve treatment for patients in the future.
Purpose of the study
To investigate whether additional treatment with stereotactic radiotherapy can improve survival and whether it affects quality of life.
Study procedure
Participants in the study will be randomly assigned to one of two groups. Each group will receive one of two treatment options. If you have already started treatment selected for you by your physician, we recommend that this treatment is completed first, after which you may be included in the study.
During the first month after SABR, you will have follow-up visits once a week, and thereafter once a month until the third month after the last dose of SABR. If you do not have any symptoms, your condition may be checked by telephone. Additional examinations may also be performed if needed.
Imaging-based assessments will be carried out according to the hospital’s usual practice. It is recommended that, during the first three years, imaging assessments are performed every three months, then every six months until the fifth year from the date of registration, and once a year thereafter.
Who can take part?
Patients with oligometastatic breast cancer, defined as five metastases or fewer.
How to apply?
If you are interested in participating or would like to find out more, please speak with your physician at the Institute of Oncology Ljubljana or contact the study staff by email at [email protected].
Participation in the study is entirely voluntary and may be withdrawn at any time without any consequences. Your identity will remain anonymous.
Participation in the study offers the possibility of access to modern forms of treatment and represents an important contribution to the development of new therapeutic options.