Postoperative treatment for recurrent breast cancer with or without heat therapy
Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
Amsterdam UMC, location VUmc · NCT06452485
This study is testing whether adding heat therapy to re-irradiation after surgery helps people with recurrent breast cancer feel better and have fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06452485 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with locoregional recurrent breast cancer who have undergone previous irradiation. It aims to collect prospective real-world data on the outcomes, toxicity, and quality of life for patients receiving postoperative re-irradiation with or without hyperthermia. The study will analyze patient-reported outcomes and adverse effects to inform future randomized trials. The goal is to standardize treatment approaches and improve decision-making for high-risk patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locoregional recurrent breast cancer who have previously received irradiation and are undergoing salvage mastectomy or local excision.
Not a fit: Patients diagnosed with primary breast sarcoma or those with low-risk locoregional recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and better quality of life for patients with recurrent breast cancer.
How similar studies have performed: While retrospective studies have shown promising results, this approach is novel as it seeks to gather prospective data on the combination of re-irradiation and hyperthermia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Previously treated with whole or partial breast irradiation. * (Neo)adjuvant systemic therapy (NST) is allowed. * Use of (FES/FDG-)PET-CT in 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. * Adequate communication and understanding skills of the Dutch language. Exclusion Criteria: * Diagnosed with primary breast sarcoma * Have a low-risk LRR after previous breast-conserving surgery/therapy
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Desiree Van Den Bongard, Dr — Amsterdam UMC
- Study coordinator: Lisca Wurfbain, MD
- Email: l.f.wurfbain@amsterdamumc.nl
- Phone: +31 6-25414750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locoregional Recurrence, Breast Cancer, Re-irradiation, Hyperthermia