Clinical trial NCT03269981: Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Keywords: Adjuvant radiotherapy
Lymphatic irradiation
Taxane
Anthracycline
Prospective study
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Radiation Oncology Group
name: Ministry of Health, Republic of Korea
First posted: 2017-09-01
Enrollment: 827
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: 7 years
Secondary outcomes:
measure: Disease-free survival according to molecular subtype
timeFrame: 5 years
measure: Treatment-related toxicity
timeFrame: 5 years
measure: European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement
timeFrame: 5 years
measure: EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Park, MD
role: STUDY_CHAIR
References: