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

Samsung Medical Center

Status

Active, not recruiting

Conditions

Breast Neoplasm

Treatments

Radiation: Whole breast and nodal irradiation

Radiation: Whole breast irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT03269981

SMC 2017-01-085-001

Details and patient eligibility

About

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).

Full description

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.

Enrollment

827 patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.