Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer

NCT06757621 | Recruiting Phase 3

• 1 other identifier: NCC4876; 24/464-4744
• Study Type: interventional
• Target: 3,142
• Locations: 1 country
• Sites: 1

Brief Summary

The role of postoperative regional nodal irradiation (RNI) for T1-2N1 intermediate-risk breast cancer is controversial, and there is a lack of class I evidence of a survival benefit from RNI. A number of retrospective studies of breast cancer patient been undertaken to risk stratify, analyse site of recurrence and assess the role of radiotherapy. RNI is currently recommended for patients at high risk of recurrence, but prospective studies in other patients are needed to assess the role of RNI. Two randomised phase III trials have confirmed the safety and efficacy of 15-fraction hypofractionated radiotherapy, while 5-fraction super-hypofractionated radiotherapy to further shorten the course of radiotherapy is a hotspot of current research. The present study aimed to investigate whether RNI improves the outcome of intermediate-risk breast cancer patients; and to assess the efficacy and toxicity of 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival Rate

  through study completion, an average of 10 year

Secondary Outcomes (6)

• Overall Survival Rate

  through study completion, an average of 10 year

• Locoregional Recurrence Rate

  through study completion, an average of 10 year

• Distant Metastasis Rate

  through study completion, an average of 10 year

• Incidence of acute and late adverse reactions

  through study completion, an average of 10 year

• Quality of life Questionnaire (EORTC QLQ-C30)

  through study completion, an average of 2 year

Study Arms (2)

Hypofractionated Postoperative Regional Nodal Irradiation

EXPERIMENTAL

Radiation: Regional Nodal Irradiation

Without Hypofractionated Postoperative Regional Nodal Irradiation

NO INTERVENTION

Interventions

Regional Nodal Irradiation RADIATION

Patients will receive chest wall / breast radiation with or without regional nodal irradiation

Hypofractionated Postoperative Regional Nodal Irradiation

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥45 years old
• Receiving breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy
• Negative surgical margins
• Tumor staging： A. patients without neoadjuvant chemotherapy: pT1-2N1M0, axillary lymph node dissection with 1-3 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) B. patients without neoadjuvant chemotherapy: pT1-2N1M0, sentinel lymph node biopsy with 1-2 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) C. patients with neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0, requiring positive clinical lymph nodes with pathological confirmation, receiving ≥6 cycles of neoadjuvant chemotherapy, and ≥3 sentinel lymph nodes detected for those with simple sentinel lymph node biopsy
• Signed informed consent

You may not qualify if:

• Distant metastases
• Metastasis to ipsilateral internal breast, supraclavicular or subclavicular lymph nodes
• Previous radiotherapy to the chest
• Bilateral breast cancer
• Pregnancy, breastfeeding
• Previous or concurrent other malignancy with tumor-free survival \<5 years (but excluding skin cancer with non-malignant melanoma, papillary/follicular thyroid cancer, cervical carcinoma in situ)

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, Beijing Municipality, 12345, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Danqiong Wang

CONTACT

086-13535684351; wdq1217ella@163.com

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: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 3, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2032
• Last Updated: January 3, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)