Breast Reconstruction and Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-22

Study Completion Date

2032-12-31

Brief Summary

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If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of radiotherapy.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients, 18 years or older, treated with mastectomy and radiotherapy for breast cancer.

Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included.

The following treatments of interest will be identified:

* "immediate breast reconstruction" (implant-based or autologous)
* "delayed breast reconstruction" group (implant-based or autologous)
* "no breast reconstruction" group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Diagnosed with unilateral non-metastatic breast cancer
* (to be) Treated with mastectomy and to be treated with adjuvant radiotherapy
* Willing and able to provide written informed consent

Exclusion Criteria

* History of DCIS or invasive breast cancer
* Previous thoracic radiotherapy treatment
* History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No