| NCT ID | NCT07178886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janine M. Simons MD PhD |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2025-08-22 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07178886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07178886 currently recruiting?
Yes, NCT07178886 is actively recruiting participants. Contact the research team at j.simons@erasmusmc.nl for enrollment information.
Where is the NCT07178886 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT07178886 clinical trial?
NCT07178886 is sponsored by Janine M. Simons MD PhD. The trial plans to enroll 750 participants.
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