Spatial Location of Breast Cancer Local Recurrence After Mastectomy

Breast Cancer Clinical Trial

— Secret  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06130111
• Other study ID #: W 21 04 00088
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastro	Maastricht	Limburg

Sponsors (18)

Lead Sponsor

Collaborator

Maastricht Radiation Oncology

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial localisation of local recurrences	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.	Up to 15 years after mastectomy
Secondary	Influence of tumour characteristics on the site of recurrence and spatial location.	Anaysis to assess whether tumour characteristics (e.g., molecular subtypes, lymphangio/lymphovascular invasion) influence the site of recurrence and spatial location.	Up to 15 years after mastectomy
Secondary	Influence of treatment-related factors on the site of recurrence and spatial location.	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.	Up to 15 years after mastectomy