breast cancer
Conditions
Interventions
single arm:preoperative Stereotactic body radiation therapy
Sponsors
The Affiliated Union Hospital of Fujian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Uni-focal lesion on mammogram ultrasound or MRI; 2. No disease on contralateral breast; 3. Histologically proven adenocarcinoma, subtypes HER2 positive (non-Luminal B) or triple negative breast cancer; 4. Advanced breast cancer: cT1-3N2-3M0, cT4N0-2M0; 5. Female, aged 18 to 8=70 years; 6. ECOG performance status of 0-1; 7. Patient has adequate bone marrow, renal and liver function; 8. WBC >= 4x10^9/L, Neutrophil>= 1.5x10^9/L, PLT >= 100x10^9/L, Hb >= 9.0g/L; 9. Total Bilirubin, AST, ALT 3.0g/dL.
Exclusion criteria
Exclusion criteria: 1. Family history of breast cancer; 2. At least 1.5cm was required between skin and tumor edge; 3. Patient has extensive micro-calcifications on mammogram; 4. Inflammatory breast cancer; 5. Ductal carcinoma in situ of the breast, without invasive tumor; 6. Lobular invasive breast cancer; 7. Patient has bilateral/contralateral breast cancer or other malignant tumor in five years; 8. Patient has metastatic disease (lung, liver); 9. Other treatment prior to the scheme; 10. Patient had treated breast or chest radiotherapy before; 11. Active connective tissue disease, especially scleroderma, systemic lupus erythematosus or collagen vascular disease; 12. Patient has active and serious cardiac or pulmonary disease or under-control infectious disease or other disease which a history of cardiac abnormalities as defined in the protocol; 13. Patients can,t write informed consent because of mental illness or other reasons; 14. Life expectancy of less than 2 years; 15. Patient has certain scores on an anxiety and depression mood questionnaires who can not; 16. Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response (pCR) rate; | — |
Countries
China
Contacts
Public ContactBenhua Xu
Department of Radiation Oncology, the Affiliated Union Hospital, Fujian Medical University
Outcome results
None listed