Radiotherapy and Long-term Outcomes in Early Breast Cancer With SLNB Omission
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorSamsung Medical Center
About this trial
This prospective, multicenter observational cohort study evaluates long-term outcomes in patients with early-stage invasive breast cancer who undergo breast-conserving surgery without sentinel lymph node biopsy or other axillary surgery and subsequently receive adjuvant radiotherapy.
The study will evaluate recurrence, survival, radiotherapy-related toxicities, and quality of life. Radiotherapy will be delivered according to routine clinical practice at each participating institution without protocol-mandated treatment assignment. Detailed radiotherapy characteristics, including treatment volume, technique, dose and fractionation, tumor-bed boost, and radiation dose to axillary lymph node levels I-III, will be prospectively collected to evaluate their associations with clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 19 years or older with histologically confirmed invasive breast cancer
Patients who have undergone breast-conserving surgery with curative intent
Patients who did not undergo axillary lymph node surgery, including sentinel lymph node biopsy, at the time of breast cancer surgery
No evidence of distant metastasis on clinical and imaging evaluation before surgery
Disqualifiers
Patients initially diagnosed with breast carcinoma in situ before surgery who did not undergo sentinel lymph node biopsy but were subsequently found to have invasive breast cancer on final surgical pathology
Receipt of neoadjuvant systemic therapy before breast cancer surgery
History of a malignancy other than breast cancer within 5 years before study enrollment, except adequately treated non-melanoma skin cancer or carcinoma in situ other than breast carcinoma in situ
Recurrent breast cancer
Trial population
Patients with histologically confirmed early-stage invasive breast cancer who have undergone breast-conserving surgery without sentinel lymph node biopsy or other axillary lymph node surgery and are scheduled to receive adjuvant radiotherapy. Eligible patients will have no evidence of distant metastasis on preoperative clinical and imaging evaluation and will be prospectively enrolled at participating institutions. Treatment decisions, including radiotherapy approach and systemic therapy, will follow routine clinical practice and will not be assigned by the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Adjuvant Breast Radiotherapy
RadiationAdjuvant radiotherapy is delivered after breast-conserving surgery according to routine clinical practice at each participating institution. Radiotherapy may include whole-breast irradiation or partial-breast irradiation, with treatment technique, dose, fractionation, and tumor-bed boost determined by the treating physician. The study does not assign or mandate a specific radiotherapy regimen.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: APROOB Cohort1 intervention
Trial outcomes
Primary outcomes
1
5-Year Recurrence-Free Survival Rate
Recurrence-free survival is defined as the time from study enrollment to the first occurrence of ipsilateral invasive breast recurrence, ipsilateral regional lymph node recurrence, distant metastasis, or breast cancer death. The 5-year recurrence-free survival rate will be estimated using the Kaplan-Meier method.
Time frame
From study enrollment to 5 yearsSecondary outcomes
1
5-Year Axillary Recurrence Rate
Axillary recurrence is defined as newly diagnosed breast cancer recurrence in the ipsilateral axillary lymph nodes after study enrollment. The 5-year cumulative incidence of axillary recurrence will be estimated.
Time frame
From study enrollment to 5 years2
5-Year Locoregional Recurrence Rate
Locoregional recurrence is defined as the first occurrence of one or more of the following after study enrollment: ipsilateral invasive breast recurrence; ipsilateral axillary lymph node recurrence; ipsilateral supraclavicular or infraclavicular lymph node recurrence; or ipsilateral internal mammary lymph node recurrence. The 5-year cumulative incidence will be estimated.
Time frame
From study enrollment to 5 years3
5-Year Distant Metastasis Rate
Distant metastasis is defined as breast cancer metastasis occurring in organs or non-regional lymph nodes outside the ipsilateral breast and ipsilateral regional lymph node regions. The 5-year cumulative incidence of the first distant metastasis after study enrollment will be estimated
Time frame
From study enrollment to 5 years4
5-Year Overall Survival Rate
Overall survival is defined as the time from study enrollment to death from any cause. The 5-year overall survival rate will be estimated using the Kaplan-Meier method.
Time frame
From study enrollment to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov