Recruiting

Postoperative Re-irradiaTion With and Without HYPERthermia, or Surgery Only: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer

ClinicalTrials.gov IDNCT06452485

PhaseNot Applicable

Enrollment500

SponsorAmsterdam UMC, location VUmc

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Locoregional Recurrence, Breast Cancer, Re-irradiation, Hyperthermia

About this study

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.

Interventions

Other: No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups. — Patients 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.

Primary outcomes

Patient-reported toxicity according to PRO-CTCAE in LRR patients (Five years)

Eligibility information

Inclusion criteria: * ≥ 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) * (Neo-)adjuvant systemic (NAST) treatment is allowed * Use of PET(FES/FDG)-CT for staging of nodal and disseminated disease * Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary/supraclavicular region (up to a maximal number of five) is allowed * Proficient in Dutch at a level allowing to understand the questionnaires and patient information sheet \* Definition of high-risk tumor characteristics are: * (Focal) irradical resection * All clinical and pathological stages except for low-risk LRR: - rcT1-2N0 - r(y)pT1-2N0 \*\* according to local clinical practice and/or shared decision making process Exclusion criteria: • Diagnosed with primary breast sarcoma

Study locations

Amsterdam UMC, Amsterdam, Netherlands

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.