Secret: Spatial Location of Breast Cancer Local Recurrence After Mastectomy

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06130111

Collaborator

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

170

Enrollment

Location

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Mastectomy

Detailed Description

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.

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastro	Maastricht	Limburg	Netherlands	6229ET

Investigators

Principal Investigator: Liesbeth Boersma, Prof., Maastro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht Radiation Oncology

ClinicalTrials.gov Identifier:

NCT06130111

Other Study ID Numbers:

W 21 04 00088

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maastricht Radiation Oncology

Mastectomy

Additional relevant MeSH terms:

Breast Neoplasms

Recurrence

Study Results

No Results Posted as of Nov 14, 2023