Breast CancerSecretNCT06130111
Spatial Location of Breast Cancer Local Recurrence After Mastectomy
An observational study of Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Non-epithelial histology.
- Primary metastatic breast cancer.
- Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
- Synchronous breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
Read the 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).
- Conditions
- Breast Cancer
- Being tested
- Mastectomy
- Keywords
- Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Mastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 years after mastectomy
Secondary outcomes (2)
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.
Measured: Up to 15 years after mastectomy
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.
Measured: Up to 15 years after mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Sep 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Schweitzer Hospital, Canisius-Wilhelmina Hospital, Diakonessenhuis, Utrecht, Erasmus Medical Center, Franciscus Gasthuis, Haaglanden Medical Centre, Jeroen Bosch Ziekenhuis, Maastricht University Medical Center, Maxima Medical Center, St. Antonius Hospital, Laurentius ziekenhuis, VieCuri Medical Centre, The Netherlands Cancer Institute, Ziekenhuis Netwerk Antwerpen (ZNA), Aarhus University Hospital, Sheba Medical Center, University of Florence
- Responsible party
- Sponsor
- Investigators
- Liesbeth Boersma, Prof., Principal investigator, Maastro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130111
- Sponsor's protocol ID
- W 21 04 00088
- Acronym
- Secret
- Status last verified
- Nov 2023
- First submitted
- 15 Jul 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Location of Breast Cancer Local Recurrence After Mastectomy: the Secret Study, a Retrospective Analysis.
- ClinicalTrials.gov ID
- NCT06130111
- Acronym / sponsor ID
- Secret / W 21 04 00088
- Conditions
- Breast Cancer
- Keywords
- Mastectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Albert Schweitzer Hospital, Canisius-Wilhelmina Hospital, Diakonessenhuis, Utrecht, Erasmus Medical Center, Franciscus Gasthuis, Haaglanden Medical Centre, Jeroen Bosch Ziekenhuis, Maastricht University Medical Center, Maxima Medical Center, St. Antonius Hospital, Laurentius ziekenhuis, VieCuri Medical Centre, The Netherlands Cancer Institute, Ziekenhuis Netwerk Antwerpen (ZNA), Aarhus University Hospital, Sheba Medical Center, University of Florence
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Non-epithelial histology.
- Primary metastatic breast cancer.
- Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
- Synchronous breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MastectomyMastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment). | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
Influence of tumour characteristics on the site of recurrence and spatial location.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liesbeth Boersma, Prof. principal investigator
Maastro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial localisation of local recurrences (time frame: Up to 15 years after mastectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.