Postoperative treatment for recurrent breast cancer with or without heat therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.