Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence

Sponsor

KK Women's and Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06088719

Collaborator

(none)

300

Enrollment

Location

432

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Recurrent Disease	Procedure: axillary surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Oncological Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence After Mastectomy

Actual Study Start Date :

Jan 1, 1989

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
axillary surgery group this group of patients had axillary surgery for axilla staging	Procedure: axillary surgery one group undergoes axillary surgery
no axillary surgery group this group of patients had no axillary surgery for axilla staging

Arm

Intervention/Treatment

axillary surgery group

this group of patients had axillary surgery for axilla staging

Procedure: axillary surgery

one group undergoes axillary surgery

no axillary surgery group

this group of patients had no axillary surgery for axilla staging

Outcome Measures

Primary Outcome Measures

recurrence [from date of surgery to date of recurrence, up to 5 years]
axillary or distant recuurences

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria: Mastectomy patients who developed pathologically confirmed invasive isolated chest wall recurrence.

Exclusion Criteria: -Patients with bilateral cancers

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KK Women's and Children's Hospital	Singapore		Singapore

Sponsors and Collaborators

KK Women's and Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

KK Women's and Children's Hospital

ClinicalTrials.gov Identifier:

NCT06088719

Other Study ID Numbers:

CIRB Ref: 2019/2419

First Posted:

Oct 18, 2023

Last Update Posted:

Oct 18, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Recurrence

Study Results

No Results Posted as of Oct 18, 2023