Locally advanced breast cancer (cN2b-cN3c stage) with residual positive lymph nodes in the internal mammary lymph node and/or supraclavicular and/or infraclavicular regions after surgery
Conditions
Interventions
Patients with residual lymph nodes in the clavicle and/or internal mammary regions after surgery for local advanced breast cancer:Proton + Carbon Ion Multi-Beam Radiation Therapy
Sponsors
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed invasive breast cancer; 2.Patients with clinical stage cN2b-cN3c who have residual positive regional (internal mammary/supraclavicular-infraclavicular) lymph nodes after systemic therapy and are planned to receive postoperative adjuvant radiotherapy; 3.Expected survival >= 12 months; 4.Age between 18-80 years old; 5.Excluded distant metastasis by CT, MRI, bone scan or PET/CT, etc; 6.ECOG performance status 0–2; 7.Patients must sign the informed consent for radiotherapy;
Exclusion criteria
Exclusion criteria: 1.Invasive breast cancer without pathological confirmation; 2.Patients with clinical stage cN2b–cN3c who achieve complete response in regional (internal mammary/supraclavicular-infraclavicular) lymph nodes after systemic therapy, with no radiologically detectable residual disease; 3.With distant metastasis; 4.Prior radiotherapy to the ipsilateral chest or breast; 5.Inability to meet predefined dose constraints for organs at risk; 6.Pregnancy (confirmed by serum or urine ß-HCG test) or during lactation; 7.Poor general health status (KPS2); 8.Severe comorbidities or factors that may interfere with radiotherapy; 9.Unable to understand the purpose of the treatment or unwilling to sign the informed consent for treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5 years locoregional relapse-free survival,5y-LRRFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| distant metastasis?free survival, DMFS;acute (within 3 months) adverse reactions and late (more than 3 months) adverse reactions after radiotherapy;Quality of life,QOL;overall survival, OS;disease-free survival,DFS; | — |
Countries
China
Contacts
Public ContactQing Zhang
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Outcome results
None listed