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

NCT06452485 | Recruiting DMC

• 1 other identifier: 2012094
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locoregional Recurrence; Breast Cancer; Re-irradiation; Hyperthermia

Keywords

locoregional recurrence, breast cancer, treatment, re-irradiation, hyperthermia, patient-reported outcomes, quality of life, toxicity

Outcome Measures

Primary Outcomes (1)

• 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.

  Five years

Secondary Outcomes (7)

• Quality of Life at 2 and 5 years after diagnosis of LRR disease

  at 2 and 5 years after diagnosis of LRR disease

• Quality of Life at 2 and 5 years after diagnosis of LRR disease

  at 2 and 5 years after diagnosis of LRR disease

• LRR-free survival in LRR patients

  at 2 and 5 years after diagnosis of LRR disease

• distant metastasis-free survival in LRR patients

  at 2 and 5 years after diagnosis of LRR disease

• breast-cancer event-free survival in LRR patients

  at 2 and 5 years after diagnosis of LRR disease

Study Arms (3)

Postoperative re-irradiation with hyperthermia

Postoperative re-irradiation with hyperthermia in patients with locoregional recurrent breast cancer

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

Postoperative re-irradiation without hyperthermia

Postoperative re-irradiation without hyperthermia in patients with locoregional recurrent breast cancer

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

surgery only

Patients who do not receive postoperative re-irradiation after salvage mastectomy.

Interventions

No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups. OTHER

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.

Postoperative re-irradiation with hyperthermia; Postoperative re-irradiation without hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• ≥ 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

You may not qualify if:

• Diagnosed with primary breast sarcoma

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Borstkanker Onderzoek Groep: collaborator
• Comprehensive Cancer Centre The Netherlands: collaborator
• Dutch Cancer Society: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Hyperthermia

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Desiree Van Den Bongard, Dr

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisca Wurfbain, MD

CONTACT

+31 6-25414750; l.f.wurfbain@amsterdamumc.nl

Desiree Van Den Bongard, Dr

CONTACT

+31 6-25414750; h.j.vandenbongard@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: June 11, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

NL (1)