Clinical trial NCT06130111: Spatial Location of Breast Cancer Local Recurrence After Mastectomy
Official title: Spatial Location of Breast Cancer Local Recurrence After Mastectomy: the Secret Study, a Retrospective Analysis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Mastectomy
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Albert Schweitzer Hospital
name: Canisius-Wilhelmina Hospital
name: Diakonessenhuis, Utrecht
name: Erasmus Medical Center
name: Franciscus Gasthuis
name: Haaglanden Medical Centre
name: Jeroen Bosch Ziekenhuis
name: Maastricht University Medical Center
name: Maxima Medical Center
name: St. Antonius Hospital
name: Laurentius ziekenhuis
name: VieCuri Medical Centre
name: NKI-AvL
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Aarhus University Hospital
name: Sheba Medical Center
name: University of Florence
First posted: 2023-11-14
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local or regional recurrence or distant metastases as the first site of failure.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Non-epithelial histology.
* Primary metastatic breast cancer.
* Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
* Synchronous breast cancer.

Primary outcomes:
measure: Spatial localisation of local recurrences
timeFrame: Up to 15 years after mastectomy
Secondary outcomes:
measure: Influence of tumour characteristics on the site of recurrence and spatial location.
timeFrame: Up to 15 years after mastectomy
measure: Influence of treatment-related factors on the site of recurrence and spatial location.
timeFrame: Up to 15 years after mastectomy
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastro
state: Limburg
Study officials:
affiliation: Maastro
name: Liesbeth Boersma, Prof.
role: PRINCIPAL_INVESTIGATOR
References: