About this trial
A prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females who are at least 18 years of age on the day of signing the informed consent form.
Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology.
Patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (MDT) at the stage of brain metastasis.
Patients with a traceable medical history during the treatment period.
Disqualifiers
The subject has leptomeningeal metastasis.
If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
The subject has not signed the informed consent form.
Pregnant or breastfeeding women.
Trial population
The study plans to enroll 100 subjects with breast cancer brain metastasis. These subjects have been assessed by a multidisciplinary team (MDT) and are planned to receive or have already received intracranial radiotherapy. They are also planned to receive or are currently receiving treatment with novel anti-tumor drugs \[including: ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc.\].
Trial design
Cohort
Prospective
Treatments tested in this trial
Radiotherapy + Novel Anti-tumor Drug
Drug1. Novel anti-tumor drugs \[including: ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc.\] 2. Radiotherapy
Treatment groups
Trial outcomes
Primary outcomes
Intracranial Progression-Free Survival
The time from the randomization of the subject to the first documented tumor progression (PD) or death due to any cause.
Sponsors and contacts
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