Spatial Location of Breast Cancer Local Recurrence After Mastectomy
- Conditions
- Breast Cancer
- Registration Number
- NCT06130111
- Lead Sponsor
- Maastricht Radiation Oncology
- Brief Summary
Rationale:To improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy, the exact localization of regions at risk for a local recurrence should be known. However, there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy.
Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy.
Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure.
Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
- Detailed Description
Rationale:To improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy, the exact localization of regions at risk for a local recurrence should be known. However, there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy.
Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy. Secondary objectives are to assess whether tumour characteristics (e.g., molecular subtypes, lymphangio/lymphovascular invasion) and treatment-related factors (e.g., PMRTwith or without bolus, radiation volumes, doses) influence the site of recurrence and spatial location.
Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure.
Primary endpoint: Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
Other study parameters: First descriptive statistics will be performed to investigate whether there is a relation between the localization of the recurrence and the type of mastectomy: modified radical mastectomy (MRM), skin-sparing mastectomy (SSM), nipple sparing mastectomy (NSM).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 170
- Age 18 years and more at the time of breast cancer diagnosis.
- Proven histology of first invasive breast cancer
- Mastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment).
- Having a local recurrence, as primary event
- reast cancer diagnosis in the period 2003-2008.
- Non-epithelial histology.
- Primary metastatic breast cancer.
- Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
- Synchronous breast cancer.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spatial localisation of local recurrences Up to 15 years after mastectomy The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy.
- Secondary Outcome Measures
Name Time Method Influence of tumour characteristics on the site of recurrence and spatial location. Up to 15 years after mastectomy Anaysis to assess whether tumour characteristics (e.g., molecular subtypes, lymphangio/lymphovascular invasion) influence the site of recurrence and spatial location.
Influence of treatment-related factors on the site of recurrence and spatial location. Up to 15 years after mastectomy Anaysis to assess whether treatment-related factors (e.g., PMRT with or without bolus, radiation volumes, doses) influence the site of recurrence and spatial location.
Trial Locations
- Locations (1)
Maastro
🇳🇱Maastricht, Limburg, Netherlands