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Trial Title:
Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
NCT ID:
NCT05933733
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Salvage treatment (surgery and/or radiation therapy)
Description:
Appropriate salvage treatment (surgery and/or radiation therapy) will be selected by the
treating clinicians considering the disease status.
Arm group label:
Salvage treatment after locoregional recurrence
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)
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Haeyoung Kim, MD, PhD
Phone:
82-2-3410-2612
Email:
haeyoung0131.kim@samsung.com
Start date:
July 4, 2023
Completion date:
July 2033
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05933733
