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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 with a traceable medical history during the treatment period.

Disqualifiers

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.

Trial population

The study plans to enroll 100 subjects with breast cancer brain metastasis. These subjects have been assessed by a multidisciplinary team (MDT) and are planned to receive or have already received intracranial radiotherapy. They are also planned to receive or are currently receiving treatment with novel anti-tumor drugs \[including: ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc.\].

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiotherapy + Novel Anti-tumor Drug

    Drug

    1. Novel anti-tumor drugs \[including: ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc.\] 2. Radiotherapy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Intracranial Progression-Free Survival

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

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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