Breast Cancer
Conditions
Interventions
Hypofractionated Radiotherapy:Prescription dose:
43.5 Gy in 15 fractions,2.9 Gy per fraction per day, delivered 5 times per week.
Breast-conserving patients tumor bed dose: 49.5 Gy in 15 fractions, 3.
Conventional fractionation radiotherapy:Prescription dose:
50 Gy in 25 fractions, 2 Gy per fraction per day, delivered 5 times per week.
Breast-conserving patients tumor bed dose: 57.5 Gy in 25 fract
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Voluntarily participate and sign a written informed consent form. 2)Histologically confirmed breast cancer, undergo baseline breast MRI or PET/MRI before treatment. 3)Undergo curative surgery for breast cancer (either breast-conserving surgery or mastectomy with axillary lymph node dissection). 4)Postoperative pathology confirms invasive cancer, negative margins, =1 axillary lymph node metastasis, and clear molecular subtyping. 5)Age =18 years, ECOG performance status 0-1, expected survival > 5 years. 6)Complete surgical wound healing without wound infection, etc. 7)Meet indications and basic requirements for radiotherapy and chemotherapy, including normal peripheral blood counts, no significant abnormalities in cardiac, liver, kidney functions, normal ECG, and receiving standard adjuvant systemic treatment based on molecular subtyping. 8)Patients who have not received chest radiotherapy previously. 9)Willing to participate in the study, good compliance, able to cooperate with trial observations, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or women of childbearing potential not using contraception. 2.Number of dissected axillary lymph nodes < 10. 3.Pathologically confirmed ipsilateral supraclavicular lymph node positive (N3) or primary tumor T4. 4.Patients concurrently participating in other clinical trials. 5.Undergoing stage I or II breast reconstruction surgery. 6.Receiving neoadjuvant chemotherapy, targeted therapy, or neoadjuvant endocrine therapy. 7.Unable to start radiotherapy within 12 weeks after breast cancer curative surgery or within 8 weeks after completion of adjuvant chemotherapy. 8.Synchronous contralateral breast cancer. 9.Pathologically or radiologically confirmed distant metastasis. 10.History of prior radiation therapy to the neck, chest, or ipsilateral axilla. 11.Significant non-oncological internal medical conditions affecting the implementation of radiotherapy. 12.Uncontrolled neurological, psychiatric disorders, or mental illness affecting compliance, cooperation, and reporting of treatment responses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-Year Locoregional Recurrence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-Year Distant Metastasis Rate;5-Year invasive disease free survival;5-Year Overall Survival Rate;Acute Radiotherapy-Related Adverse Reactions;Late Radiotherapy-Related Adverse Reactions;Evaluation of Cosmetic Outcomes in Patients after Breast-Conserving Surgery;Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactXinchen SUN
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Outcome results
None listed