Breast cancer
Conditions
Interventions
Omission of radiation therapy after breast-conserving surgery
Sponsors
Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed invasive breast cancer (irrespective of histological type). 2) TNM classification: pT1-T2pN0 3) Partial mastectomy is performed by vertical resection in which lateral stump can be diagnosed. 4) There is no residual cancer on the skin or pectoralis major muscle. 5) Partial mastectomy specimens are pathologically examined at intervals of 5 mm, and an experienced breast pathologist has concluded complete resection (the distance from the lateral stump to the cancer cells is longer than 5 mm). 6) Histologically no lymph-vascular invasion detected. 7) Age at registration is 20 years or older 8) Performance status (ECOG) is 0 or 1. 9) Main organ functions are maintained. 10) Patients have given their consent to participate in the study through the documents.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of invasive cancer in the preserved breast (limited to the first recurrence) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakayuki Ueno
Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Breast Surgical Oncology, Breast Oncology Center
Outcome results
None listed