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NCT Number: NCT06839547

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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location status: Recruiting

Location contact

MaFei Professor

CONTACT

[email protected]

13910217780

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Radiotherapy + Novel Anti-tumor Drug

Drug
  • 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.]
  • Radiotherapy

Primary outcomes

  1. Intracranial Progression-Free Survival

    Time frame: 24 months

    The time from the randomization of the subject to the first documented tumor progression (PD) or death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Ma, Professor

CONTACT

[email protected]

13910217780

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.