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Breast Neoplasms

Breast Diseases

Skin Diseases

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Taxane

Post-lumpectomy radiotherapy to the whole breast alone.

Post-lumpectomy radiotherapy to the whole breast and regional lymph node.

Whole breast irradiation

Radiotherapy to the whole breast and regional lymph nodes.

Whole breast and nodal irradiation

Won Park, MD

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).

Objective:

* Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy.
* Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.
* Compare the treatment-related toxicities between the WBI and WB+RNI.
* Compare the patient's quality of life between the WBI and WB+RNI.

Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy \[SLN\] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive WB+RNI.
* Arm II: Patients receive WBI alone.

Arm circumference and quality of life (EORTC QLQ-C30 \& EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years.

Patients are followed at 3 months after completion of radiotherapy and annually thereafter for seven years.

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

A Phase III Prospective Randomized Study of Elective Regional Lymph Node Irradiation in Pathologic N1 Breast Cancer Patients Treated With Breast Conserving Surgery

Disease-free survival according to molecular subtype

1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.

1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer	NCT03269981	Breast Neoplasm	Whole breast ir... Whole breast an...	20 Years - 70 Years	Samsung Medical Center
Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer	NCT03269981	Breast Neoplasm	Whole breast ir... Whole breast an...	20 Years - 70 Years	Samsung Medical Center

Spots Global Cancer Trial Database for lymphatic irradiation