Breast CancerSALT-LRRNCT05933733
Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
An observational study of Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Salvage treatment (surgery and/or radiation therapy)
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jul 2023to Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not anticipated for complying the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Haeyoung Kim, MD, PhD, 82-2-3410-2612, haeyoung0131.kim@samsung.com
About this study
Official title: 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:
Read more
- 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)
- Conditions
- Breast Cancer
- Being tested
- Salvage treatment (surgery and/or radiation therapy)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Salvage treatment (surgery and/or radiation therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The event for progression-free survival was defined as any disease progression or breast cancer-related death.
Measured: 5 years from the initiation of the salvage therapy
Rate of adverse events
Adverse events related to the salvage therapy will be reported and incidence rate will be calculated.
Measured: 5 years from the initiation of the salvage therapy
Secondary outcomes (4)
Locoregional failure rate
The event for locoregional failure rate was defined as recurrence in breast / chest wall or regional lymph node area.
Measured: 5 years from the initiation of the salvage therapy
Cancer-specific survival
The event for cancer-specific survival was defined as death of the participant related to the breast cancer.
Measured: 5 years from the initiation of the salvage therapy
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.
Measured: 5 years from the initiation of the salvage therapy
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.
Measured: 5 years from the initiation of the salvage therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start4 Jul 2023
- Primary completionJul 2028 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haeyoung Kim, Samsung Medical Center
- Investigators
- Haeyoung Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933733
- Sponsor's protocol ID
- 2023-05-023
- Acronym
- SALT-LRR
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT05933733
- Acronym / sponsor ID
- SALT-LRR / 2023-05-023
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salvage treatment after locoregional recurrence | – | Other: 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not anticipated for complying the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Salvage treatment after locoregional recurrence |
Primary outcome
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.
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.
4 secondary outcomes
Locoregional failure rate
Time frame: 5 years from the initiation of the salvage therapy
Cancer-specific survival
Time frame: 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
Breast cosmesis
Time frame: 5 years from the initiation of the salvage therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haeyoung Kim principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haeyoung Kim, MD, PhD (82-2-3410-2612, haeyoung0131.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 5 years from the initiation of the salvage therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.