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.
≥ 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)
None
Eligible patients with local and/or regional recurrence (LRR), i.e true recurrence or second primary tumor: 1. After previous breast-conserving therapy and LRR with high-risk characteristics\* treated with salvage mastectomy after previous mastectomy or salvage mastectomy and postoperative re-irradiation +/- hyperthermia treatment. In both groups (neo)-adjuvant treatment 2. After previous mastectomy with a chest wall recurrence treated with local excision with or without NAST and postoperative re irradiation (+/-hyperthermia). If these patients have a complete clinical/radiological response after NAST and no surgery (i.e. local excision) is performed, treatment with re-irradiation (with/without hyperthermia) is indicated. Treatment with regional re-irradiation in case of a regional recurrence after (targeted) axillary dissection is allowed.
Cohort
Prospective
No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.
Other interventionPatients will receive standard of care. Patients need to fill in questionnaires, these are additional interventions for the included subject. Questionnaires for patient-reported outcomes (PROMs) and toxicity will be filled in one week before treatment, one week before re-irradiation, one week and three months after re-irradiation, one, two and five years after surgery.
Patient-reported toxicity according to PRO-CTCAE in LRR patients
Patient-reported toxicity according to PRO-CTCAE after a median follow-up of five years after diagnosis of (subsequent) LRR disease.
Quality of Life at 2 and 5 years after diagnosis of LRR disease
EORTC-C30
Quality of Life at 2 and 5 years after diagnosis of LRR disease
EORTC -BR45
LRR-free survival in LRR patients
distant metastasis-free survival in LRR patients
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Amsterdam UMC, location VUmc
Lead sponsor
Borstkanker Onderzoek Groep
Collaborator
Comprehensive Cancer Centre The Netherlands
Collaborator
Dutch Cancer Society
Collaborator
