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A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer

A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer

Recruiting
18 years and older
All
Phase N/A

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Overview

A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.

Eligibility

Inclusion Criteria:

Subjects are eligible for inclusion in the study only if all the following criteria apply:

  1. Men or women who are 18 years of age or older on the day of signing the informed consent;
  2. Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
  3. Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
  4. Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;
  5. Patients with a traceable medical history during treatment;
  6. Subjects who are able to sign an informed consent to participate in the study.

Exclusion Criteria:

  1. Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;
  2. Have not signed the informed consent form;
  3. Pregnant or lactating women;
  4. Other conditions deemed unsuitable for inclusion in the study by the investigator.

Study details
    Advanced Breast Cancer

NCT06776861

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

15 October 2025

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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