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Spatial Location of Breast Cancer Local Recurrence After Mastectomy

Spatial Location of Breast Cancer Local Recurrence After Mastectomy: the Secret Study, a Retrospective Analysis.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06130111
Acronym
Secret
Enrollment
170
Registered
2023-11-14
Start date
2021-09-01
Completion date
2024-01-01
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Mastectomy

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).

Interventions

PROCEDUREMastectomy

Mastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment).

Sponsors

Albert Schweitzer Hospital
CollaboratorOTHER
Canisius-Wilhelmina Hospital
CollaboratorOTHER
Diakonessenhuis, Utrecht
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Franciscus Gasthuis
CollaboratorOTHER
Haaglanden Medical Centre
CollaboratorOTHER
Jeroen Bosch Ziekenhuis
CollaboratorOTHER
Maastricht University Medical Center
CollaboratorOTHER
Maxima Medical Center
CollaboratorOTHER
St. Antonius Hospital
CollaboratorOTHER
Laurentius ziekenhuis
CollaboratorUNKNOWN
VieCuri Medical Centre
CollaboratorOTHER
NKI-AvL
CollaboratorUNKNOWN
Ziekenhuis Netwerk Antwerpen (ZNA)
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Sheba Medical Center
CollaboratorOTHER_GOV
University of Florence
CollaboratorOTHER
Maastricht Radiation Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Spatial localisation of local recurrencesUp to 15 years after mastectomyThe 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

MeasureTime frameDescription
Influence of tumour characteristics on the site of recurrence and spatial location.Up to 15 years after mastectomyAnaysis 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 mastectomyAnaysis to assess whether treatment-related factors (e.g., PMRT with or without bolus, radiation volumes, doses) influence the site of recurrence and spatial location.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026