Brain-metastasis breast cancer: testing a radiosensitizer with radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational cohort study enrolling adults with inoperable, metastatic breast cancer that has reached the brain. Participants receive intracranial radiotherapy alongside a physician-chosen novel anti-tumor drug and are followed to monitor safety and any signs of effectiveness. The study does not randomize treatments but documents outcomes in real-world practice. Data collected include treatment details, adverse events, and clinical status over time. The aim is to see how well the combination works and whether it is safe in routine care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fei Ma, Professor
• Email: drmafei@126.com
• Phone: 13910217780

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.