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

NCT05059379 | Recruiting Phase 3

• 1 other identifier: FDRT-BC017
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer; Radiotherapy; Complications; Effect of Radiation Therapy

Keywords

breast cancer; supraclavicular lymph node; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS )

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

  Up to 5 years after completion of radiation therapy

Secondary Outcomes (7)

• Overall survival (OS)

  Up to 5 years after completion of radiation therapy

• Ipsilateral supraclavicular lymph node recurrence (ISLNR) )

  Up to 5 years after completion of radiation therapy

• Local reigonal recurrence (LRR)

  Up to 5 years after completion of radiation therapy

• Distance metastasis (DS)

  Up to 5 years after completion of radiation therapy

• incidence of adverse events

  Up to 5 years after completion of radiation therapy

Study Arms (2)

Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)

ACTIVE COMPARATOR

Radiation 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.

Radiation: Medial supraclavicular lymph node radiotherapy

Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)

EXPERIMENTAL

Radiation 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.

Radiation: Entire supraclavicular lymph node radiotherapy

Interventions

Entire supraclavicular lymph node radiotherapy RADIATION

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.

Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)

Medial supraclavicular lymph node radiotherapy RADIATION

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

Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fudan University: lead
• The First Affiliated Hospital of University of Science and Technology of China: collaborator
• Quanzhou First Hospital: collaborator
• Jiangyin People's Hospital: collaborator
• Affiliated Hospital of Jiangnan University: collaborator
• Guizhou Provincial People's Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38195438 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Zhaozhi Yang, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaomao Guo

  Fudan University

  STUDY CHAIR

Central Study Contacts

Zhaozhi Yang, M.D.

CONTACT

86 18017317126; yzzhi2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 28, 2021
• Study Start: September 20, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)