Breast Cancer
Conditions
Interventions
Preoperative Neoadjuvant Hypofractionated Radiotherapy Group:For patients with stable disease (SD) or progressive disease (PD) on imaging after preoperative neoadjuvant chemotherapy, hypofractionated
Postoperative Adjuvant Hypofractionated Radiotherapy Group:For patients with stable disease (SD) or progressive disease (PD) on imaging after preoperative neoadjuvant chemotherapy, timely breast cance
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate and sign a written informed consent form. 2.Age 18-75 years, no gender restrictions. 3.ECOG performance status score of 0-2. 4.Histologically confirmed newly diagnosed breast cancer. 5.Locally advanced: T1-4N3M0, T3-4NxM0. 6.Clinical and imaging evaluation of stable disease (SD) or progressive disease (PD) after neoadjuvant chemotherapy or targeted therapy. 7.No severe abnormalities in hematopoietic, cardiac, pulmonary, hepatic, or renal functions, and no immunodeficiency. 8.Expected survival > 12 months.
Exclusion criteria
Exclusion criteria: 1.The total dose of the radiotherapy plan cannot reach 49.5 Gy in 15 fractions while ensuring normal tissue limits. 2.Presence of a large breast tumor causing severe pain or significant bleeding. 3.Major surgery within 28 days prior to the start of the study treatment. 4.Presence of a second primary tumor (except for basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma with more than 3 years of disease-free survival post-treatment). 5.History of chest radiotherapy or chemotherapy. 6.Use of other investigational drugs or participation in other clinical trials within 30 days prior to randomization. 7.Pregnant, lactating, or of childbearing potential without the use of contraception. 8.Substance abuse, long-term heavy alcohol consumption, HIV/AIDS, uncontrolled epilepsy, or loss of self-awareness due to mental illness; deemed unsuitable for the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year local-regional control rate;2-year local-regional control rate;1-year local progression-free survival (LPFS);2-year local progression-free survival (LPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate (pCR);Surgical Complications;Radiation-Related Side Effects; | — |
Countries
China
Contacts
Public ContactXinchen SUN
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Outcome results
None listed