About this trial
In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and intermediate- and high-risk factors are treated with surgery with or without postoperative re-irradiation with or without hyperthermia. Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83%, and severe toxicity in up to 40% of LRR patients. Unfortunately, no prospective (randomized) data are available on clinical outcomes. Consequently, variation exists in hyperthermia-treatment and re-irradiation schedules. Prospective real-world data on oncological outcomes, toxicity and quality of life is highly needed for shared decision-making between patients and professionals. These data will be used in the design of a future randomized trial in high-risk LRR patients.
Eligibility criteria
Qualifiers
≥ 18 years old
WHO performance scale ≤ 2
Diagnosed with local +/- regional recurrence (LRR) (i.e. true recurrence or second primary) with high-risk tumor characteristics* and previously treated with postoperative local +/- regional irradiation for primary breast cancer/previous recurrence with an indication for salvage mastectomy with/without postoperative re-irradiation (+/-hyperthermia)** if re-irradiation: including overlap of re-irradiated volume with previous irradiated volume
Diagnosed with a chest wall recurrence and treated with local excision with/without NAST and postoperative re irradiation with/without hyperthermia. In patients with a clinical/radiological complete response after neoadjuvant systemic treatment, NO surgery and re irradiation (+/- hyperthermia) (since surgery is not possible in this group)
Disqualifiers
None
Trial design
Treatments tested in this trial
- No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.
Treatment groups
Sponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
Borstkanker Onderzoek Groep
Collaborator
Comprehensive Cancer Centre The Netherlands
Collaborator
Dutch Cancer Society
Collaborator