Postoperative radiotherapy is a conventional treatment for breast cancer patients with a high risk of recurrence, such as those with regional lymph node metastasis, especially TNBC. However, the optimal mode of treatment for the combination of radiotherapy and immunotherapy has not yet been determined, especially in the adjuvant treatment phase. There is still a lack of validation and high-grade evidence on the safety and synergistic efficacy of radiotherapy-immunotherapy combinations. In this study, we aimed to compare the safety and preliminary efficacy of hypofractionated radiotherapy and concurrent immunotherapy with those of hypofractionated radiotherapy and sequential immunotherapy in the postoperative adjuvant stage through prospective real-world studies for TNBC patients, and focused on verifying the incidence of adverse reactions in radiotherapy and immunotherapy in the adjuvant stage, so as to find out the optimal combination mode of postoperative radiotherapy combined with immunotherapy, further reduce the distant metastasis of TNBC patients under the premise of ensuring safety, and improve long-term survival.
Study Type
OBSERVATIONAL
Enrollment
250
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Incidence of grade 3-4 adverse reactions
Treatment-related adverse reactions are defined as those within 120 days of radiotherapy or during and after immunotherapy.
Time frame: From enrollment to 4 months after the end of treatment
ipsilateral breast tumor recurrence
Any ipsilateral chest wall, breast recurrence events during the follow-up period
Time frame: From date of enrollment, through study completion, an average of 5 years
Local-regional Recurrence
Any ipsilateral chest wall, breast, regional lymph node recurrence event during the follow-up period
Time frame: From date of enrollment, through study completion, an average of 5 years
Distant metastasis
Any distant metastasis during the follow-up period.
Time frame: From date of enrollment, through study completion, an average of 5 years
Distant metastasis free survival
The time from the date of randomization of the subject to the earliest occurrence of distant metastases or death
Time frame: From date of enrollment, through study completion, an average of 5 years
Disease free survival
The time from the date of randomization of the subject to the time of disease recurrence or death of the patient due to disease progression
Time frame: From date of enrollment, through study completion, an average of 5 years
Overall Survival
From the date of randomization of the subject to the death of the patient.
Time frame: From date of enrollment, through study completion, an average of 5 years
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