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.

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new anti-tumor drug to see how well it works when combined with radiation therapy for patients with advanced breast cancer that has spread to the brain. The goal is to find out if this drug can help make the radiation treatment more effective and safe for patients. The study is not yet recruiting participants, but it aims to include adults aged 18 and older who have advanced breast cancer that cannot be surgically removed and has spread to the brain.

To join the trial, patients need to have a confirmed diagnosis of this type of cancer and be scheduled to receive radiation therapy. They should also be receiving or have recently received a specific type of treatment that includes various novel anti-tumor drugs. Participants will be monitored throughout the study to track their health and treatment responses. It’s important to note that individuals with certain brain conditions or severe symptoms may not qualify. If you're interested in this study, you would need to provide informed consent and be willing to participate in the treatment and follow-up assessments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females who are at least 18 years of age on the day of signing the informed consent form.
• • 2. Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology.
• • 3. 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.
• 4. 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.
• • 5. Patients with a traceable medical history during the treatment period.
• • 6. Patients who are able to sign the informed consent form to participate in the study.
• Exclusion Criteria:
• • 1. The subject has leptomeningeal metastasis.
• • 2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
• • 3. The subject has not signed the informed consent form.
• • 4. Pregnant or breastfeeding women.
• • 5. Other situations deemed by the investigator as unsuitable for inclusion in the study.