breast cancer
Conditions
Interventions
Radiotherapy group 5F:Prevention zone 5.2Gy × 5F
Sequential supplementation of tumor bed with 2.9Gy x 3F
Radiotherapy group 10F:Prevention zone 3.65Gy × 10F
tumor bed sequential supplementation 2.9Gy × 3F
Sponsors
The first Medical Center of PLA General Hospital, Beijing
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years with pathologically confirmed breast cancer. 2. Underwent breast-conserving surgery (BCS) + sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). 3. Indicated for adjuvant radiotherapy. 4. No distant metastasis. 5. Expected survival >=6 months. 6. Adequate organ function*. 7. Able to comply with follow-up requirements. 8. Willing and able to provide informed consent. 9. Women of childbearing potential must use effective contraception.
Exclusion criteria
Exclusion criteria: 1. Surgical site conditions:Nipple-areola complex (NAC) not preserved in the affected breast; Significant volume reduction compared to the contralateral breast;Postoperative breast deformity. 2. Expected intolerance to radiation-induced organ toxicity. 3. History of acute/chronic nerve injury within or adjacent to the planned radiation field. 4. History of acute/chronic neuritis within or adjacent to the planned radiation field. 5. Prior radiotherapy to the same or adjacent anatomical site. 6. Concurrent enrollment in other radiation therapy clinical trials. 7. Severe underlying medical conditions. 8. Significant impairment of organ function. 9. Pregnancy or lactation. 10. Active connective tissue disease (e.g., lupus, scleroderma). 11. Other malignancies affecting life expectancy, except: Adequately treated basal cell carcinoma of skin; Carcinoma in situ of cervix; Superficial bladder tumors (=T1); Early-stage thyroid cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation-induced late skin toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Localized recurrence rate;Distant transfer rate;overall survival rate; | — |
Countries
China
Contacts
Public ContactMeng Lingling
Department of Radiation Oncology,The first Medical Center of PLA General Hospital, Beijing
Outcome results
None listed