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NCT Number: NCT05933733

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)

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salvage treatment (surgery and/or radiation therapy)

Other

Appropriate salvage treatment (surgery and/or radiation therapy) will be selected by the treating clinicians considering the disease status.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haeyoung Kim, MD, PhD

CONTACT

[email protected]

82-2-3410-2612

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: SALT-LRR

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Jul 6, 2023
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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