NCT06088719

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1989

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1989

Completed
34.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

36 years

First QC Date

October 12, 2023

Last Update Submit

October 12, 2023

Conditions

Breast CancerRecurrent Disease

Outcome Measures

Primary Outcomes (1)

  • recurrence

    axillary or distant recuurences

    from date of surgery to date of recurrence, up to 5 years

Study Arms (2)

axillary surgery group

this group of patients had axillary surgery for axilla staging

Procedure: axillary surgery

no axillary surgery group

this group of patients had no axillary surgery for axilla staging

Interventions

axillary surgeryPROCEDURE

one group undergoes axillary surgery

axillary surgery group

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

female patients with breast cancer with mastectomy and has isolated chest wall recurrences.

You may not qualify if:

  • Patients with evidence of concomitant distant or/and regional recurrences
  • Patients who did not have surgery for their isolated chest wall recurrences.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Geok hoon lim

CONTACT

lim.gh@singhealth.com.sg

Study Design

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

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

January 1, 1989

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

SG(1)