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Phase II clinical study of regional lymph node radiotherapy after breast cancer surgery

Phase II clinical study of regional lymph node radiotherapy after breast cancer surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077338
Enrollment
Unknown
Registered
2023-11-06
Start date
2023-11-08
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

single arm:Change the single dose, number of divisions, and duration of treatment for postoperative regional lymph node radiotherapy

Sponsors

Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Basic requirements for enrolled patients: 1) Voluntarily participate in and sign informed consent in person 2) Age > 18 years old, 2mm 9) The results of ER, PR, HER2 and Ki-67 indexes of breast primary lesions were obtained 10) Women in the reproductive period should use contraception for at least one month before screening, and commit to use contraception throughout the study period and continue to the specified time after the study

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Number of axillary lymph node dissection<10 2) Pathologically confirmed ipsilateral supraclavicular lymph node positive patients 3) Patients with ipsilateral internal mammary lymph node metastasis confirmed by pathology or imaging 4) Pregnant or lactating women 5) Receive stage I or II Breast reconstruction 6) There are serious non neoplastic medical complications that affect the implementation of radiotherapy 7) Malignant tumor history in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin carcinoma in situ and cervical Carcinoma in situ) 8) Simultaneous contralateral breast cancer 9) Previous history of neck, chest, or ipsilateral axillary radiotherapy 10) Active collagen vascular disease 11) Remote site metastasis confirmed by pathology or imaging 12) Patients with primary mass staging of T4 13) Radiotherapy cannot be started within 12 weeks (or 8 weeks from the end of adjuvant chemotherapy) after breast cancer radical surgery (breast preservation surgery or mastectomy) 14) Other reviewers believe from the registration study that there are sufficient reasons for disqualification, such as potential discrepancies with the clinical protocol; Unable or unwilling to sign an informed consent form; Patients with mental illness or those who are unable to cooperate in treatment issued by medical institutions.

Design outcomes

Primary

MeasureTime frame
Local recurrence rate;

Secondary

MeasureTime frame
5-year distant metastasis rate;5-year survival rate without invasive tumor recurrence;

Countries

CHINA

Contacts

Public ContactYaoxiong Xia

Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)

55490850@qq.com+86 138 8826 5611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026