Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Not Applicable
Recruiting
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000040249
- Lead Sponsor
- Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 600
Inclusion Criteria
Not provided
Exclusion Criteria
1) Cases of additional resection during surgery(However, registration is possible if the specimen before additional resection can be diagnosed as complete resection) 2) Cases of excisional biopsy 3) Patients who have not undergone standard surgery on lymph nodes 4) BRCA mutation positive cases 5)When the doctor in charge determines that it is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of invasive cancer in the preserved breast (limited to the first recurrence)
- Secondary Outcome Measures
Name Time Method 1. Incidence of cancer in the preserved breast 2. Incidence of true recurrence (TR) and new primary lesion (NP) 3. Recurrence-free survival rate 4. Overall survival rate 5. Search for risk factors for ipsilateral breast cancer (Age, ER status, PgR status, HER2 status, tumor diameter, Nuclear grade) 6. Incidence of contralateral breast cancer 7. Incidence of distant metastases 8. Incidence of local recurrence rate 9. Incidence of symptomatic pneumonitis 10. Incidence rate of symptomatic cardiac dysfunction 11. Incidence and degree of skin disorders