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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Fei Ma, Professor
drmafei@126.com
13910217780
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2028-09-10
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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