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

Breast Cancer Clinical Trial

— SALT-LRR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933733
• Other study ID #: 2023-05-023
• Status: Recruiting
• Start date: July 4, 2023
• Est. completion date: July 2033

Study information

• Verified date: January 2024
• Source: Samsung Medical Center
• Contact: Haeyoung Kim, MD, PhD
• Phone: 82-2-3410-2612
• Email: haeyoung0131.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 2033
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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
Primary	Rate of adverse events	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	Locoregional failure rate	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
Secondary	Cancer-specific survival	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
Secondary	Quality of life (BREAST-Q)	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
Secondary	Breast cosmesis	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