Spatial Location of Breast Cancer Local Recurrence After Mastectomy

NCT06130111 | Unknown

• 1 other identifier: W 21 04 00088
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Influence of tumour characteristics on the site of recurrence and spatial location.

  Up to 15 years after mastectomy

• Influence of treatment-related factors on the site of recurrence and spatial location.

  Up to 15 years after mastectomy

Interventions

Mastectomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Maastro

Maastricht, Limburg, 6229ET, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Liesbeth Boersma, Prof.

  Maastro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: November 14, 2023
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)