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Breast CancerPhase 3NCT04320979

Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients

A Phase 3 study testing internal mammary nodal irradiation and no internal mammary nodal irradiation in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
internal mammary nodal irradiation and no internal mammary nodal irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteChina
Study dates
8 May 2020to May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

Official title: Postmastectomy Prophylactic Internal Mammary Nodal Irradiation for High-risk Patients With Non-metastatic Breast Cancer

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.

Read the detailed description

Eligible patients are randomized into 2 groups: chest wall/whole breast and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall/whole breast and supraclavicular nodal +-axillary nodal irradiation. The prescription dose is 50 Gy in 25 fractions over 5 weeks or 43.5Gy in 15 fractions over 3 weeks. Breast cancer patients treated with breast-conserving surgery will receive tumor bed boost.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Conditions
Breast Cancer
Being tested
internal mammary nodal irradiation, no internal mammary nodal irradiation
Keywords
breast neoplasm, mastectomy, radiotherapy, internal mammary node
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04320979
Study groupRoleWhat they receive
internal mammary nodal irradiationExperimentalchest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
Receives: Radiation: internal mammary nodal irradiation
no-internal mammary nodal irradiationActive comparatoripsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation
Receives: Radiation: no internal mammary nodal irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (8)

  1. overall survival

    the incidence of death due to any cause.

    Measured: 5 years

  2. cumulative internal mammary nodal recurrence

    ipsilateral internal mammary nodal relapse during follow up.

    Measured: 5 years

  3. cumulative locoregional recurrence

    ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal relapse during follow up.

    Measured: 5 years

  4. distant metastasis

    the incidence of first relapse beyond locoregional region.

    Measured: 5 years

  5. contralateral non-invasive breast cancer or other malignant tumors

    the incidence of contralateral invasive breast cancer or other malignant tumors developed after enrollment.

    Measured: 5 years

  6. major cardiovascular events

    the incidence of death due to coronary heart disease or other heart disease, development of myocardial infarction, coronary recanalization, or hospitalization for a major cardiovascular events (such as heart failure, valvular disease, arrhythmia, unstable angina, or other major cardiovascular event).

    Measured: 5 years

  7. incidence of adverse events

    graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 3.0.

    Measured: 5 years

  8. quality of life

    questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start8 May 2020
  3. Primary completion1 Nov 2025
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320979
Sponsor's protocol ID
19/317-2101
Status last verified
Jan 2026
First submitted
19 Mar 2020
Last updated
13 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Owing to concerns regarding patient privacy.

Publications

  • 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.

    PubMed 34742270

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing internal mammary nodal irradiation and no internal mammary nodal irradiation in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04320979, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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