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NCT Number: NCT03269981

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

whole breast irradiation

Radiation

Radiotherapy to the whole breast alone.

Whole breast and nodal irradiation

Radiation

Radiotherapy to the whole breast and regional lymph nodes.

Primary outcomes

  1. Disease-free survival

    Time frame: 7 years

    Disease-free survival

Secondary outcomes

  1. Disease-free survival according to molecular subtype

    Time frame: 5 years

    Disease-free survival according to molecular subtype

  2. Treatment-related toxicity

    Time frame: 5 years

    acute and chronic toxicities

  3. European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement

    Time frame: 5 years

    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.

  4. EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Korean Radiation Oncology Group
  • Ministry of Health, Republic of Korea

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2029
Study completion
2029
First posted
Sep 1, 2017
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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