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NCT Number: NCT06757621

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

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Beijing, Beijing Municipality, 12345, China

Location status: Recruiting

Location contact

Dan-Qiong Wang

CONTACT

[email protected]

13535684351

Shu-Lian Wang

CONTACT

[email protected]

87788625

Shu-Lian Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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)

Treatment and study plan

Regional Nodal Irradiation

Radiation

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

Primary outcomes

  1. Disease-Free Survival Rate

    Time frame: through study completion, an average of 10 year

Secondary outcomes

  1. Overall Survival Rate

    Time frame: through study completion, an average of 10 year

    Survival

  2. Locoregional Recurrence Rate

    Time frame: through study completion, an average of 10 year

    Survival

  3. Distant Metastasis Rate

    Time frame: through study completion, an average of 10 year

    Survival

  4. Incidence of acute and late adverse reactions

    Time frame: through study completion, an average of 10 year

    CommonTerminology Criteria for Adverse Events (CTCAE) verson 5.0 and Toxicity Criteria of Radiation Therapy Oncology Group (RTOG) are uesd for assessment. Higher toxicity ratings indicate more severe reactions.

  5. Quality of life Questionnaire (EORTC QLQ-C30)

    Time frame: through study completion, an average of 2 year

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) .For the Functioning Scale and the Overall Quality of Life Scale, higher scores indicate better functioning or quality of life

  6. European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)

    Time frame: through study completion, an average of 2 year

    for the Symptom Scale/Individual Measures, higher scores indicate more severe symptoms or problems.

Study contacts

Contact information is provided by the study sponsor or research team.

Danqiong Wang

CONTACT

[email protected]

086-13535684351

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer: A Multicenter Prospective Randomized Phase III Trial and Cohort Study.

Important dates

Study start
2024
Primary completion
2029
Study completion
2032
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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