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NCT06839547Recruiting

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.

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

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 (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
18 Feb 2025
Start date
1 Mar 2025
Primary completion date
10 Sept 2028
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT06839547

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Mar 2025 to the primary completion date, 10 Sept 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.

Other

  • The subject has leptomeningeal metastasis.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.