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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
100 participants
Mar 1, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include:
- 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.
- Patients with a traceable medical history during the treatment period.
- Patients who are able to sign the informed consent form to participate in the study.
Exclusion Criteria5
- 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.
- Other situations deemed by the investigator as unsuitable for inclusion in the study.
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Interventions
1. 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06839547