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ID
Source
Brief title
Health condition
Breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary focus of this project will be to determine which different combinations of (oncoplastic reconstructive) surgery and radiotherapy techniques, in the context of breast conserving therapy for (pre-invasive) breast cancer, contribute the most to the development of fibrosis.
Secondary outcome
To assess the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms.
Background summary
One in seven women will be diagnosed with breast cancer at some point during life. The majority of patients (60-70%) can be treated with breast conserving therapy consisting of lumpectomy (instead of mastectomy) combined with a sentinel node procedure or axillary lymph node dissection, followed by irradiation of the breast. A lot of patients also receive chemotherapy.
As life expectancy after breast cancer treatment has become substantially longer due to improved multimodality treatment, late adverse effects of the treatment affecting quality of life (QoL) have become increasingly important. Unfortunately, breast fibrosis occurs as a late adverse event in a substantial subset of patients (10-30%) after breast conserving therapy for DCIS or breast cancer. Fibrosis can be painful and may result in poor cosmetic outcome. Fibrosis as well as poor cosmetic outcome can negatively affect QoL. Besides patient and tumor related factors, both surgery and radiotherapy play a role in the risk of developing fibrosis.
Both surgical and radiation oncologists aim for the best cosmetic outcome and QoL of each patient, without compromising oncological safety. However, especially in the light of current oncoplastic reconstructive surgery techniques, it has not yet been properly investigated how the different surgery and radiotherapy techniques interact.
The primary focus of this project will be to determine which different combinations of (oncoplastic reconstructive) surgery and radiotherapy techniques, in the context of breast conserving therapy for (pre-invasive) breast cancer, contribute the most to the development of fibrosis. Second, to assess the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms.
Study objective
Surgical and radiation oncologists aim for the best cosmetic outcome and QoL of each patient, without compromising oncological safety. However, especially in the light of current oncoplastic reconstructive surgery techniques, it has not yet been properly investigated how the different surgery and radiotherapy techniques interact.
Study design
4-6 years after treatment (1 time point)
Inclusion criteria
• Female patients aged ≥ 18 years
• History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer (pT1-3N0-2a) or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed.
• Breast conserving surgery between 1st of January 2016 and 31th of December 2018
• Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy, with or without boost
• Adequate understanding of the Dutch language and written informed consent
Exclusion criteria
• Any breast surgery or re-irradiation on the breast area after BCT
• Progression of disease (and additional treatment) since BCT
• Patients who received partial breast irradiation
• Current pregnancy or breast feeding
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9840 |
| Other | METC Erasmus MC : MEC-2021-0829 |