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Breast CancerPhase 3SUCLANODENCT05059379

Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

A Phase 3 study testing Entire supraclavicular lymph node radiotherapy and Medial supraclavicular lymph node radiotherapy in people with Breast Cancer and Radiotherapy; Complications, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Entire supraclavicular lymph node radiotherapy and Medial supraclavicular lymph node radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,650 participants
Where
1 siteChina
Study dates
20 Sep 2021to Aug 2027
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG 0-1
  • Newly diagnosed invasive breast cancer
  • Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administered：clinical stage III or pathological stage is T1-4N1-3a/bM0.
  • Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with ≥10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon.
  • Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based).
  • Enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy.
  • For ER and/or PR positive patients, the duration of anticipated endocrine therapy should be≥5 year ; For HER2 postive patients, the duration of anticipated herceptin should be 1 year.
  • Writtern, informed consent.

Who cannot join

  • Initinal clinical diagnosis N3c (supraclavicualr node metastasis)
  • T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy
  • Distant metastasis
  • Bilateral breast cancer or previously contralateral breast cancer
  • Positve sentinal lymph node with no axillary dissection
  • ECOG ≥2
Show all 14Show fewer
  • Could not tolerate chemotherapy and anti-HER2 target treatment
  • Active infectious
  • History of radiotherapy
  • Serious medical complcation
  • Breast cancer during pregnancy and lactation
  • Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ.
  • Inaccessibility for follow-up
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhaozhi Yang, M.D. contact

86 18017317126

yzzhi2014@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Zhaozhi C Yang, +8618017317126, yzzhi2014@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

Read the detailed description

PRIMARY OBJIECTIVE:

  1. To evaluate whether entire supraclavicular lymph node irradiation is superior to medial supraclavicular lymph node irradiation in terms of disease free survival for patients with positive lymph nodes and high risk of recurrence after breast cancer surgery

SECONDARY OBJECTIVES:

  1. To estimate the difference of overall survival II. to estimate the difference of ipsilateral supraclavicular node recurrence III. to estimate the difference of local regional recurrence IV. to estimate the difference of radiation related toxicities and quality of life.

Outline: Beginning 2-12 weeks after the completion of breast cancer surgery and neoadjuvant/adjuvant chemotherapy, patients are randomized to 1 of 2 treatment arms Arm I: Patients undergo breast/chest wall, undissected axillary, internal mammary node and medial supraclavicular node radiation. Conventional fractionated radiotherapy 50Gy/25Fx/5w or hypofractionated 42.5Gy/16Fx/3.5week with IMRT or VAMT technique is recommended. 3DCRT technique is not permitted.

Arm II: Patients undergo breast/chest wall, undissected axillary, internal mammary node and entire supraclavicular node radiation. Conventional fractionated radiotherapy 50Gy/25Fx/5w or hypofractionated 42.5Gy/16Fx/3.5week with IMRT or VAMT technique is recommended. 3DCRT technique is not permitted

Being tested
Entire supraclavicular lymph node radiotherapy, Medial supraclavicular lymph node radiotherapy
Keywords
breast cancer, supraclavicular lymph node, radiotherapy
Medical subject headings
Breast Neoplasms, Radiation Injuries

What participants receive

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

  • Entire supraclavicular lymph node radiotherapyRadiation

    Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.

  • Medial supraclavicular lymph node radiotherapyRadiation

    Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.

Study groups in NCT05059379
Study groupRoleWhat they receive
Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)Active comparatorRadiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and medial supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.
Receives: Radiation: Medial supraclavicular lymph node radiotherapy
Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)ExperimentalRadiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.
Receives: Radiation: Entire supraclavicular lymph node radiotherapy

What is being measured

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

  1. Disease free survival (DFS )

    defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer

    Measured: Up to 5 years after completion of radiation therapy

Secondary outcomes (7)

  1. Overall survival (OS)

    defined as time from any death

    Measured: Up to 5 years after completion of radiation therapy

  2. Ipsilateral supraclavicular lymph node recurrence (ISLNR) )

    defined as entire ipsilateral supraclavicular lymph node recurrence

    Measured: Up to 5 years after completion of radiation therapy

  3. Local reigonal recurrence (LRR)

    chest wall, breast , regional lymph node recurrence

    Measured: Up to 5 years after completion of radiation therapy

  4. Distance metastasis (DS)

    any recurrence in all areas beyond local, regional and death due to breast cancer

    Measured: Up to 5 years after completion of radiation therapy

  5. incidence of adverse events

    Adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0)

    Measured: Up to 5 years after completion of radiation therapy

  6. difference of quality of life

    evaluate the quality of life according to EROTC-QLQ-C30 and QLQ BR23

    Measured: Up to 5 years after completion of radiation therapy

  7. differences in upper limb function

    evaluate the upper limb function by Quick-dash

    Measured: Up to 5 years after completion of radiation therapy

Timeline

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

  1. First posted28 Sep 2021
  2. Study start20 Sep 2021
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2027 (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
1,650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05059379
Sponsor's protocol ID
FDRT-BC017
Acronym
SUCLANODE
Status last verified
Oct 2021
First submitted
10 Sep 2021
Last updated
25 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang L, Mei X, Hu Z, Yu B, Zhang C, Li Y, Liu K, Ma X, Ma J, Chen X, Meng J, Shi W, Wang X, Mo M, Shao Z, Zhang Z, Yu X, Guo X, Yang Z. Adjuvant medial versus entire supraclavicular lymph node irradiation in high-risk early breast cancer (SUCLANODE): a protocol for a multicenter, randomized, open-label, phase 3 trial. BMC Cancer. 2024 Jan 9;24(1):49. doi: 10.1186/s12885-024-11831-8.

    PubMed 38195438

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Entire supraclavicular lymph node radiotherapy and Medial supraclavicular lymph node radiotherapy in people with Breast Cancer and Radiotherapy; Complications, run by Fudan University 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Oct 2021. 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?

Contact Zhaozhi Yang, M.D. (86 18017317126, yzzhi2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (DFS ) (time frame: Up to 5 years after completion of radiation therapy). 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 NCT05059379, 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 25 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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