NCT04320979

Brief Summary

The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy or breast-conserving surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
50mo left

Started May 2020

Longer than P75 for phase_3 breast-cancer

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 Progress60%
May 2020May 2030

First Submitted

Initial submission to the registry

March 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Expected
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5.5 years

First QC Date

March 19, 2020

Last Update Submit

January 10, 2026

Conditions

Breast Cancer

Keywords

breast neoplasmmastectomyradiotherapyinternal mammary node

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    failure: relapse of ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal or distant metastasis or contralateral invasive breast cancer or death due to any cause.

    5 years

Secondary Outcomes (8)

  • overall survival

    5 years

  • cumulative internal mammary nodal recurrence

    5 years

  • cumulative locoregional recurrence

    5 years

  • distant metastasis

    5 years

  • contralateral non-invasive breast cancer or other malignant tumors

    5 years

  • +3 more secondary outcomes

Other Outcomes (1)

  • Exploratory Translational Research

    5 year

Study Arms (2)

internal mammary nodal irradiation

EXPERIMENTAL

chest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation

Radiation: internal mammary nodal irradiation

no-internal mammary nodal irradiation

ACTIVE COMPARATOR

ipsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation

Radiation: no internal mammary nodal irradiation

Interventions

internal mammary nodal irradiationRADIATION

chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Patients treated with breast-conserving surgery will receive tumor bed boost. Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.

internal mammary nodal irradiation
no internal mammary nodal irradiationRADIATION

chest wall/whole breast and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.

no-internal mammary nodal irradiation

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group Performance Status Scale 0-2
  • Histologically confirmed invasive breast cancer
  • Underwent total mastectomy/breast-conserving surgery and axillary dissection(10 or more axillary lymph nodes detected) and negative margins
  • Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1， IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy
  • No supraclavicular or internal mammary nodes metastases based on images before system therapy
  • No distant metastases
  • Could tolerate radiotherapy
  • Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles)
  • Anticipated to receive endocrine therapy for 5 years if indicated
  • Anticipated to receive anti-HER2 therapy for 1 years if indicated
  • LVEF≥50% based on echocardiogram
  • Willing to follow up
  • Written,informed consent

You may not qualify if:

  • Simultaneous bilateral breast cancer
  • Sentinel lymph node biopsy only without axillary dissection
  • Had received internal mammary node dissection
  • No imaging assessment of the internal mammary nodal before system therapy
  • One-stage breast reconstruction
  • Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease
  • Had history of chest wall or supraclavicular radiotherapy
  • Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (1)

  • Zhao XR, Fang H, Tang Y, Hu ZH, Jing H, Liang L, Yan XN, Song YW, Jin J, Liu YP, Chen B, Tang Y, Qi SN, Li N, Lu NN, Men K, Hu C, Zhang YH, Li YX, Wang SL. POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial. BMC Cancer. 2021 Nov 6;21(1):1185. doi: 10.1186/s12885-021-08852-y.

    PMID: 34742270DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shu-lian Wang, M.D

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Ye-xiong Li, M.D

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 25, 2020

Study Start

May 8, 2020

Primary Completion

November 1, 2025

Study Completion (Estimated)

May 1, 2030

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Owing to concerns regarding patient privacy.

Locations

CN(1)