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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03269981
• Other study ID #: SMC 2017-01-085-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 30, 2029

Study information

• Verified date: November 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 827
• Est. completion date: December 30, 2029
• Est. primary completion date: December 30, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Samsung Medical Center	Korean Radiation Oncology Group, Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival	7 years
Secondary	Disease-free survival according to molecular subtype	Disease-free survival according to molecular subtype	5 years
Secondary	Treatment-related toxicity	acute and chronic toxicities	5 years
Secondary	European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement	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.	5 years
Secondary	EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement	1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.	5 years