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

October 12, 2023 updated by: KK Women's and Children's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1989

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref: 2019/2419

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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