This study aims to evaluate the efficacy and safety of hyperfractionated radiotherapy (40Gy/15 fractions) compared to conventional fractionated radiotherapy (50Gy/25 fractions) in breast cancer patients undergoing breast reconstruction through a three-phase randomized controlled non-inferiority clinical trial. The primary objective is to verify that hyperfractionated radiotherapy is non-inferior to conventional fractionated radiotherapy in terms of local area control; the secondary objectives are to compare the main complications of wounds, acute and chronic toxic reactions, breast cosmetic effects, and quality of life between the two groups, thereby providing high-level evidence-based medical evidence for optimizing postoperative radiotherapy regimens for breast cancer and promoting individualized treatment. Additionally, the molecular characteristics of blood samples will be studied to identify biomarkers related to the radiotherapy process and treatment response, providing high-level evidence for immediate medium-dose low-fractionation radiotherapy after different reconstructions.
Female, aged 18 - 75 years
Karnofsky score ≥ 60
Invasive breast adenocarcinoma confirmed by histopathology
Total mastectomy (with or without preservation of nipple-areola complex) + axillary lymph node dissection/ sentinel lymph node biopsy + R0 implantation/expansion placement (negative margins) pT3 or N2-3 stage or pT1-2N1 disease
If a patient has bilateral breast cancer, they will be excluded; those with distant metastasis or metastasis in the supraclavicular or internal mammary lymph nodes; those who have received radiotherapy in the past; those who have had or are currently suffering from malignant tumors, except for non-pigmented skin cancer; those who are pregnant; those with active collagen vascular diseases or other serious diseases, such as alcohol and drug abuse or mental disorders.
Patients with severe dysfunction of the heart, liver, or kidneys.
Patients with a history of radiotherapy or those who are contraindicated to radiotherapy.
Pregnant or lactating women.
Parallel
Whole-dose radiotherapy
RadiationThe radiotherapy plan for the large-dose fractionation group: 45 Gy / 15 fractions / 3 weeks
Conventional fractionated radiotherapy
RadiationConventional fractionated radiotherapy plan: 50 Gy / 25 fractions / 5 weeks
Local Control Rate
Local recurrence rate: Regular imaging examinations (such as mammography, MRI, and ultrasound) are conducted to monitor the recurrence of tumors in the breast area. Local recurrence is typically defined as the reappearance of a lump at the original tumor site or in the breast reconstruction area, or as confirmed malignant tumor cells through biopsy.
Complications after breast reconstruction surgery
Post-operative complications of breast reconstruction refer to the core complications that affect the survival of the reconstruction, lead to a second operation, or seriously affect the quality of life of the patient. The observation period is within 2 years. The removal of the implant or the occurrence of capsular contracture ≥ Baker grade III, the rate of severe capsular contracture: This is the most significant physical failure mode of pseudo-weight reconstruction. Reconstruction failure rate: Requires a second operation to remove the implant or replace the flap.
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