Spatial Location of Breast Cancer Local Recurrence After Mastectomy (Secret)

November 7, 2023 updated by: Maastricht Radiation Oncology

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ET
        • Maastro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial localisation of local recurrences
Time Frame: 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.
Up to 15 years after mastectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of tumour characteristics on the site of recurrence and spatial location.
Time Frame: 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.
Up to 15 years after mastectomy
Influence of treatment-related factors on the site of recurrence and spatial location.
Time Frame: 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.
Up to 15 years after mastectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Collaborators

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

Investigators

  • Principal Investigator: Liesbeth Boersma, Prof., Maastro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Estimated)

November 14, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W 21 04 00088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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