Safety of Omitting Axillary Surgery in Breast Cancer Pati... | NCT06088719

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

NCT06088719

Sponsor

KK Women's and Children's Hospital

Status

Unknown status

Last Update Posted

Oct 18, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Breast Cancer
Recurrent Disease

Interventions

axillary surgery

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1989Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 12, 2023

First Submission Date that Met QC Criteria

Oct 12, 2023

First Posted Date

Oct 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2023

Last Update Posted Date

Oct 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
axillary surgery	Procedure	one group undergoes axillary surgery	axillary surgery group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence	axillary or distant recuurences	from date of surgery to date of recurrence, up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Geok hoon lim	Contact			lim.gh@singhealth.com.sg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KK Women's and Children's Hospital	Recruiting	Singapore			Singapore

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D012008	Recurrence

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided