Breast Reconstruction and Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization
Overview
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.
Primary outcome measures
- Patient satisfaction at 1 year [Time frame: From enrollment to one year follow-up after treatment.]
- Patient quality of life at 1 year [Time frame: From enrollment to one year follow-up after treatment.]
Secondary outcome measures (7)
- Patient satisfaction at 3 and 5 years [Time frame: From enrollment to 3 and 5 years follow-up after treatment.]
- Patient quality of life at 3 and 5 years [Time frame: From enrollment to 3 and 5 years follow-up after treatment.]
- Complications prior to and following radiotherapy [Time frame: From enrollment to end of study follow-up (i.e. 5 years after treatment).]
- Cost-effectiveness and consumption of medical care and materials. [Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
- Time to adjuvant treatment (radiotherapy/systemic therapy). [Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
- Breast cancer recurrence rates at 3, and 5 years [Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
- Recurrence free interval, disease free survival and overall survival at 3 and 5 years. [Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Identifiers
NCT: NCT07178886 · 10390032310055 · 10390032310055