Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Salvage treatment (surgery and/or radiation therapy)

• Registration Number: NCT05933733
• Lead Sponsor: Samsung Medical Center

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study Start: 2023-07-04
• Study First Posted: 2023-07-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-27
• Last Update Posted: 2024-01-30
• Primary Completion: 2028-07
• Study Completion: 2033-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Salvage treatment after locoregional recurrence	Salvage treatment (surgery and/or radiation therapy)	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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.
Rate of adverse events	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.

Secondary Outcome Measures

Name	Time	Method
Cancer-specific survival	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.
Breast cosmesis	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.
Locoregional failure rate	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.
Quality of life (BREAST-Q)	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of