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

Breast Cancer Clinical Trial

— SUCLANODE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059379
• Other study ID #: FDRT-BC017
• Status: Recruiting
• Phase: Phase 3
• Start date: September 20, 2021
• Est. completion date: August 2027

Study information

• Verified date: October 2021
• Source: Fudan University
• Contact: Zhaozhi Yang, M.D.
• Phone: 86 18017317126
• Email: yzzhi2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

PRIMARY OBJIECTIVE:

I. 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:

I. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: August 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. ECOG 0-1

2. Newly diagnosed invasive breast cancer

3. 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.

4. 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.

5. Should receive =6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based).

6. 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.

7. 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.

8. Writtern, informed consent.

Exclusion Criteria:

1. Initinal clinical diagnosis N3c (supraclavicualr node metastasis)

2. T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy

3. Distant metastasis

4. Bilateral breast cancer or previously contralateral breast cancer

5. Positve sentinal lymph node with no axillary dissection

6. ECOG =2

7. Could not tolerate chemotherapy and anti-HER2 target treatment

8. Active infectious

9. History of radiotherapy

10. Serious medical complcation

11. Breast cancer during pregnancy and lactation

12. Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ.

13. Inaccessibility for follow-up

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Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiotherapy; Complications

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Fudan University	Affiliated Hospital of Jiangnan University, Guizhou Provincial People's Hospital, Jiangyin People's Hospital, Quanzhou First Hospital, The First Affiliated Hospital of University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	defined as time from any death	Up to 5 years after completion of radiation therapy
Secondary	Ipsilateral supraclavicular lymph node recurrence (ISLNR) )	defined as entire ipsilateral supraclavicular lymph node recurrence	Up to 5 years after completion of radiation therapy
Secondary	Local reigonal recurrence (LRR)	chest wall, breast , regional lymph node recurrence	Up to 5 years after completion of radiation therapy
Secondary	Distance metastasis (DS)	any recurrence in all areas beyond local, regional and death due to breast cancer	Up to 5 years after completion of radiation therapy
Secondary	incidence of adverse events	Adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0)	Up to 5 years after completion of radiation therapy
Secondary	difference of quality of life	evaluate the quality of life according to EROTC-QLQ-C30 and QLQ BR23	Up to 5 years after completion of radiation therapy
Secondary	differences in upper limb function	evaluate the upper limb function by Quick-dash	Up to 5 years after completion of radiation therapy