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

Not Applicable

Active, not recruiting

• Conditions: Breast Neoplasm
• Interventions: Radiation: Whole breast irradiation; Radiation: Whole breast and nodal irradiation

• Registration Number: NCT03269981
• Lead Sponsor: Samsung Medical Center

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-27
• Primary Completion: 2029-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 827

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole breast irradiation	Whole breast irradiation	Post-lumpectomy radiotherapy to the whole breast alone.
Whole breast and nodal irradiation	Whole breast and nodal irradiation	Post-lumpectomy radiotherapy to the whole breast and regional lymph node.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	7 years	Disease-free survival

Secondary Outcome Measures

Name	Time	Method
Treatment-related toxicity	5 years	acute and chronic toxicities
European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement	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.
Disease-free survival according to molecular subtype	5 years	Disease-free survival according to molecular subtype
EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement	5 years	1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of