breast cancer
Conditions
Interventions
Intensity modulated radiotherapy (IMRT) technique will be used on the MRIdian (ViewRay, USA). In a single fraction, 18 Gy is prescribed to the PTV.
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients fulfilling all the following criteria will be included in this study. Preoperative eligibility criteria will include: 1) No evidence of multiple tumors on mammography, ultrasound, and MRI 2) No preoperative systemic therapy 3) No lymph node or distant metastases on all preoperative examination Operative and pathological eligibility criteria will include: 1) Partial lumpectomy or quadrantectomy with sentinel lymph node biopsy 2) Pathologically T1 invasive carcinoma or DCIS less than 2.5 cm in diameter 3) Pathologically negative margins, defined as tumor at 2 mm or more from the inked edge for both DCIS and invasive carcinomas 4) Pathologically N0 5) No multi-centric carcinoma 6) Estrogen receptor positive 7) No lymphovascular space invasion or extensive intraductal component Other eligibility criteria are follows: 1) Japanese women aged 40 and over 2) Performance status 0 or 1 3) No history of chest irradiation 4) Ability to provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria will be excluded from this study: 1) Any other concomitant active malignancy 2) Infections requiring systemic treatment 3) Pregnancy or nursing 4) Inability to remain in the supine position 5) Active collagen disease 6) Active interstitial pneumonitis or lung fibrosis 7) Myocardial infarction or angina pectoris within 6 months 8) Inability to perform MRI due to claustrophobia or metal implants 9) Confirmed BRCA mutation carrier (Genetic testing is not mandatory)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of Grade 2 or higher late adverse events (AEs), which could be related to treatment, occurring between 91 days and 3 years from the irradiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of early AEs, which included all events regardless of relation to treatment occurring within 90 days from the irradiation, overall survival (OS), disease-free survival (DFS), ipsilateral-breast relapse-free survival (IBRFS), location of breast recurrence in relation to irradiated site, the proportion of breast cosmetic change and the proportion of treatment completion. | — |
Countries
Japan
Contacts
Public ContactKana Takahashi
National Cancer Center Hospital Department of Radiation Oncology
Outcome results
None listed