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Clinical Trials in South Korea / NCT03269981
Active, not recruiting Not applicable

Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer

NCT03269981 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2017-04-01
Last updated
2023-11-27

Condition(s) studied

Breast Neoplasm

Investigational drug(s) / intervention(s)

Whole breast irradiationWhole breast and nodal irradiation

Whole breast irradiation: Radiotherapy to the whole breast alone.

Whole breast and nodal irradiation: Radiotherapy to the whole breast and regional lymph nodes.

Study summary

This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically proven invasive carcinoma of the breast. * One to three positive axillary lymph nodes (pN1) proven in pathologic specimen. * Prior breast-conserving surgery and post-operative adjuvant chemotherapy including taxane. * Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor. * Administering anti-HER2 therapy in cases with HER2-positive tumor. Exclusion Criteria: * Metastases in supraclavicular or internal mammary lymph nodes. * Metastases in distant organs. * Neoadjuvant chemotherapy or hormone therapy before surgery. * Not receiving adjuvant anthracycline and taxane. * Bilateral breast cancer * Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph nodes. * Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of the cervix, or skin cancer.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03269981 on ClinicalTrials.gov ↗ ← All trials in South Korea