Breast Reconstruction and Radiotherapy

NCT07178886 | Recruiting

• 1 other identifier: 10390032310055
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Mastectomy; Radiotherapy; Reconstruction; Quality of life; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction at 1 year

  The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire BREAST-Q. With the BREAST-Q questionnaire, four domains will be evaluated (psychosocial well-being (score ranges from 10 to 50), physical well-being (score ranges from 10 to 30), sexual well-being (score ranges from 6 to 30) and satisfaction with breasts (score ranges from 4 to 16) and higher scores indicate better outcomes.

  From enrollment to one year follow-up after treatment.

• Patient quality of life at 1 year

  The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire EQ-5D-5L. The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life).

  From enrollment to one year follow-up after treatment.

Secondary Outcomes (7)

• Patient satisfaction at 3 and 5 years

  From enrollment to 3 and 5 years follow-up after treatment.

• Patient quality of life at 3 and 5 years

  From enrollment to 3 and 5 years follow-up after treatment.

• Complications prior to and following radiotherapy

  From enrollment to end of study follow-up (i.e. 5 years after treatment).

• Cost-effectiveness and consumption of medical care and materials.

  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).

  Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).

Study Arms (1)

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

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janine M. Simons MD PhD: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Maastro Clinic, The Netherlands: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Janine M Simons, MD PhD

CONTACT

0031107040521; j.simons@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: September 17, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be shared and reused only if and dependent on whether access to the data is approved by the Sponsor and PI of the study.
• Access Criteria: The purpose of the request should be provided in writing. If a data transfer is agreed upon, the data will be shared according to the Erasmus MC guidelines on data security and after a DTA has been signed by both parties.

Locations

NL (1)