Breast Cancer
Conditions
Interventions
Ultra-hypofractionated whole-breast irradiation (26 Gy in 5 fractions over 5 days) followed by sequential boost irradiation (5.2 Gy in 1 fraction over 1 day) after breast-conserving surgery.
Sponsors
Kobe City Hospital Organization, Kobe City Medical Center General Hospital (Clinical Departments I, II, and III)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) No distant metastasis is detected in all preoperative examinations. 2) Patients who have undergone breast-conserving surgery. 3) Postoperative pathological findings meet the following criteria 1. Histological type is invasive carcinoma or ductal carcinoma in situ. 2. Pathological stage corresponds to pT0-3 pN0-1. The following cases are also eligible. - pNX cases with cTisN0 in whom sentinel lymph node biopsy is judged unnecessary. - Cases in which neoadjuvant systemic therapy was performed and the final pathology is ypT0. * Cases with pT0 without neoadjuvant systemic therapy are not eligible. 4) Patients who meet either of the following conditions and are indicated for boost irradiation 1. Positive or close surgical margin in the pathological diagnosis. 2. Age <=50 years. 5) The interval between surgery and the start of radiotherapy is <=140 days (20 weeks). If re-excision is performed, the date of re-excision is regarded as the date of surgery. If adjuvant chemotherapy is administered, chemotherapy must be completed before the start of radiotherapy. 6) Female patients aged >=20 years. 7) Performance status (ECOG) of 0 or 1. 8) No prior history of radiotherapy to the chest. However, prior irradiation to the contralateral breast is permitted. 9) Written informed consent for participation in the study is obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Presence of active multiple primary cancers (synchronous cancers or metachronous cancers with a disease-free interval of <=5 years). However, lesions considered cured by local treatment with a prognosis comparable to carcinoma in situ and an extremely low risk of cancer-related death, as well as lesions equivalent to intramucosal carcinoma, are not regarded as active multiple primary cancers. 2) Presence of infection requiring systemic treatment. 3) Fever >=38 C. 4) Pregnant women, women who may be pregnant, or women who are breastfeeding. 5) Presence of psychiatric disease or psychiatric symptoms judged to make participation in the study difficult. 6) Diabetes mellitus requiring continuous insulin treatment or poorly controlled diabetes mellitus (HbA1c >=7.0% as a guideline). 7) Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 8) Continuous systemic steroid therapy (oral or intravenous). 9) Receiving immunosuppressive therapy due to active collagen disease. 10) History of any of the following: severe heart disease, heart failure, myocardial infarction within 6 months, or angina attack within 6 months. 11) Cases judged by the principal investigator or sub-investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute adverse events (Grade >=2) within 3 months after the start of radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcomes include overall survival, disease-free survival, ipsilateral breast tumor recurrence (IBTR)-free survival, ipsilateral breast tumor recurrence rate, and the incidence of late adverse events (Grade >=2). | — |
Countries
Japan
Contacts
Public ContactTakamasa Mitsuyoshi
Kobe City Medical Center General Hospital Department of Radiation Oncology
Outcome results
None listed