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

Conditions

Breast Neoplasm

Keywords

Adjuvant radiotherapy, Lymphatic irradiation, Taxane, Anthracycline, Prospective study

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.

Kim N, Park W, Kim H, Cho WK, Ahn SJ, Kim MY, Park SH, Lee IJ, Ha I, Kim JH, Kim TH, Lee KC, Lee HS, Kim TG, Shin KH, Lee JH, Jung J, Cho O, Kim YB, Kim ES, Jo IY, Koo T, Kim K, Park HJ, Shin YJ, Ha B, Kwon J, Lee JH, Moon S.

2024-09-24

10.1016/j.ijrobp.2024.09.017

Patient-reported outcomes in N1 breast cancer: A phase III trial comparing whole-breast to whole-breast plus regional irradiation after taxane-based chemotherapy (KROG 1701).

Nalee Kim, Won Park, Haeyoung Kim, Won Kyung Cho, Yeon Hee Park et al. (20 authors)

Journal of Clinical Oncology2024-05-29

10.1200/jco.2024.42.16_suppl.577

Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy

Tae Hoon Lee, Ji Hyun Chang, Bum‐Sup Jang, Jae Sik Kim, Tae Hyun Kim et al. (11 authors)

BMC Cancer2022-11-169 citations

10.1186/s12885-022-10285-0

Abstract OT2-04-02: A phase 3 study of post-lumpectomy radiotherapy to whole breast + regional lymph nodes vs whole breast alone for patients with pN1 breast cancer treated with taxane-based chemotherapy (KROG 1701): Trial in progress

H Kim, W Park, D.-I. Choi, Ahn Sj, Sung Soo Kim et al. (25 authors)

Cancer Research2019-02-155 citations

10.1158/1538-7445.sabcs18-ot2-04-02

Interventions

RADIATIONWhole breast irradiation

Radiotherapy to the whole breast alone.

RADIATIONWhole breast and nodal irradiation

Radiotherapy to the whole breast and regional lymph nodes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	7 years	Disease-free survival

Secondary

Measure	Time frame	Description
Disease-free survival according to molecular subtype	5 years	Disease-free survival according to molecular subtype
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.
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.

Countries

South Korea

Outcome results

None listed