Breast Reconstruction and Radiotherapy (CONRAD)

Janine M. Simons MD PhD

Status: Enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07178886

10390032310055 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

750 participants in 1 patient group

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

Description:

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