Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer (SALT-LRR)

January 27, 2024 updated by: Haeyoung Kim, Samsung Medical Center

A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer

The purpose of this study is to evaluate clinical outcomes and adverse events of salvage treatment for locoregional recurrence of breast cancer.

The main questions it aims to answer are:

  • Clinical outcomes after salvage treatment for locoregional recurrence
  • Adverse events and quality of life after salvage treatment for locoregional recurrence
  • Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events
  • Molecular signature associated with treatment resistance

Participants will be assessed by multi-dimensional methods during and after radiation therapy:

  • Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
  • Assessment for the adverse events according to CTCAE version 5.0
  • Assessment for the molecular signature using residual tissue after pathologic diagnosis
  • Assessment for the quality of life using questionnaires (BREAST-Q)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

190

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

Non-Probability Sample

Study Population

Breast cancer patients who underwent standard treatment for initial breast cancer and experienced locoregional recurrence without distant metastasis which is eligible for salvage treatment can be enrolled for this study.

Description

Inclusion Criteria:

  • Female patients with age 18 to 100.
  • Previous standard definitive treatment for initial breast cancer
  • Locoregional recurrence without distant metastasis
  • Planned salvage treatment for locoregional recurrence
  • Informed consent of the participant

Exclusion Criteria:

- Not anticipated for complying the study protocol

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
Salvage treatment after locoregional recurrence
Participants who previously completed standard treatment for breast cancer and experienced locoregional recurrence alone will be undergo salvage treatment including surgery and/or radiation therapy.
Other: Salvage treatment (surgery and/or radiation therapy)
Appropriate salvage treatment (surgery and/or radiation therapy) will be selected by the treating clinicians considering the disease status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years from the initiation of the salvage therapy
The event for progression-free survival was defined as any disease progression or breast cancer-related death.
5 years from the initiation of the salvage therapy
Rate of adverse events
Time Frame: 5 years from the initiation of the salvage therapy
Adverse events related to the salvage therapy will be reported and incidence rate will be calculated.
5 years from the initiation of the salvage therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional failure rate
Time Frame: 5 years from the initiation of the salvage therapy
The event for locoregional failure rate was defined as recurrence in breast / chest wall or regional lymph node area.
5 years from the initiation of the salvage therapy
Cancer-specific survival
Time Frame: 5 years from the initiation of the salvage therapy
The event for cancer-specific survival was defined as death of the participant related to the breast cancer.
5 years from the initiation of the salvage therapy
Quality of life (BREAST-Q)
Time Frame: 5 years from the initiation of the salvage therapy
Quality of life of the participants will be evaluated according to the BREAST-Q™ questionnaires. Higher Q-Score indicates better quality of life.
5 years from the initiation of the salvage therapy
Breast cosmesis
Time Frame: 5 years from the initiation of the salvage therapy
Cosmesis of the breast will be evaluated according to Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/Radiation Therapy Oncology Group (RTOG) Breast Cosmesis grading scale. This is a 4-point scale (Excellent, Good, Fair, and Poor), and evaluated by the clinicians.
5 years from the initiation of the salvage therapy

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Haeyoung Kim, Samsung Medical Center

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)

July 4, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2033

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-05-023

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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