Breast CancerNCT06088719
Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence
An observational study of Breast Cancer and Recurrent Disease, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
The axillary management of breast cancer patients with operable isolated chest wall recurrence after mastectomy is unclear. We aim to determine if axillary restaging surgery can be safely omitted with no increased recurrences in this group of patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer, Recurrent Disease
- What is being tested?
- axillary surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 1989to 31 Dec 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients with breast cancer with mastectomy and has isolated chest wall recurrences.
Who may be able to join
None listed.
Who cannot join
- Patients with evidence of concomitant distant or/and regional recurrences
- Patients who did not have surgery for their isolated chest wall recurrences.
Trial locations and contacts
1 site in 1 country.
Geok hoon lim contact
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
Geok H Lim, lim.gh@singhealth.com.sg
About this study
Official title: Oncological Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence After Mastectomy
The axillary management of breast cancer patients with operable isolated chest wall recurrence after mastectomy is unclear. We aim to determine if axillary restaging surgery can be safely omitted with no increased recurrences in this group of patients.
- Conditions
- Breast Cancer, Recurrent Disease
- Being tested
- axillary surgery
- Medical subject headings
- Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary surgeryProcedure or surgery
one group undergoes axillary surgery
| Study group | Role | What they receive |
|---|---|---|
| axillary surgery group | this group of patients had axillary surgery for axilla staging Receives: Procedure: axillary surgery | |
| no axillary surgery group | this group of patients had no axillary surgery for axilla staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
axillary or distant recuurences
Measured: from date of surgery to date of recurrence, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 1989
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088719
- Sponsor's protocol ID
- CIRB Ref: 2019/2419
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence After Mastectomy
- ClinicalTrials.gov ID
- NCT06088719
- Acronym / sponsor ID
- CIRB Ref: 2019/2419
- Conditions
- Breast Cancer, Recurrent Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Jan 1989 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Oct 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.
The axillary management of breast cancer patients with operable isolated chest wall recurrence after mastectomy is unclear. We aim to determine if axillary restaging surgery can be safely omitted with no increased recurrences in this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| axillary surgery group | – | Procedure: axillary surgerythis group of patients had axillary surgery for axilla staging |
| no axillary surgery group | – | –this group of patients had no axillary surgery for axilla staging |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients with breast cancer with mastectomy and has isolated chest wall recurrences.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with evidence of concomitant distant or/and regional recurrences
- Patients who did not have surgery for their isolated chest wall recurrences.
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 |
|---|---|---|
| axillary surgeryone group undergoes axillary surgery | Procedure or surgery | axillary surgery group |
Primary outcome
recurrence
Time frame: from date of surgery to date of recurrence, up to 5 years
axillary or distant recuurences
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
Geok hoon lim contact
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 and Recurrent Disease, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 0 inclusion and 2 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 18 Oct 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 Singapore. 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?
Contact Geok hoon lim (lim.gh@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: from date of surgery to date of recurrence, up to 5 years). 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 18 Oct 2023.