NCT03269981

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
827

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Apr 2017Dec 2029

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

12.8 years

First QC Date

August 30, 2017

Last Update Submit

November 22, 2023

Conditions

Breast Neoplasm

Keywords

Adjuvant radiotherapyLymphatic irradiationTaxaneAnthracyclineProspective study

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Disease-free survival

    7 years

Secondary Outcomes (4)

  • Disease-free survival according to molecular subtype

    5 years

  • Treatment-related toxicity

    5 years

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

    5 years

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

    5 years

Study Arms (2)

Whole breast irradiation

EXPERIMENTAL

Post-lumpectomy radiotherapy to the whole breast alone.

Radiation: Whole breast irradiation

Whole breast and nodal irradiation

ACTIVE COMPARATOR

Post-lumpectomy radiotherapy to the whole breast and regional lymph node.

Radiation: Whole breast and nodal irradiation

Interventions

Whole breast irradiationRADIATION

Radiotherapy to the whole breast alone.

Whole breast irradiation
Whole breast and nodal irradiationRADIATION

Radiotherapy to the whole breast and regional lymph nodes.

Whole breast and nodal irradiation

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Won Park, MD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

April 1, 2017

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

KR(1)