In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and high-risk factors are treated with 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 comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients.
WHO performance scale ≤2
>=18 years
Patients with a LRR breast cancer after postoperative irradiation of the primary breast cancer. LRR is defined as a local and/or regional recurrence, including patients with a second primary ipsilateral breast cancer.
Patients treated with salvage mastectomy with high-risk* tumor characteristics or local excision with an indication for postoperative re-irradiation.
Diagnosed with primary breast sarcoma
Have a low-risk LRR after previous breast-conserving surgery/therapy
Patients aged 18 years and older with an indication for postoperative re-irradiation with or without hyperthermia, eligible patients with a LRR with high-risk characteristics treated with mastectomy/local excision and postoperative re-irradiation, or mastectomy/local excision and postoperative re-irradiation with hyperthermia. Patients also treated with (neo-)adjuvant systemic treatment and/or with oligometastases (\<=5 metastases), are allowed to be part of the study population.
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
