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NCT Number: NCT06776861

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

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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, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Fei Ma M.D

CONTACT

[email protected]

01087788060

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • Men or women who are 18 years of age or older on the day of signing the informed consent;
  • Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
  • Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
  • 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;
  • Patients with a traceable medical history during treatment;
  • Subjects who are able to sign an informed consent to participate in the study.

Exclusion criteria

  • 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;
  • Have not signed the informed consent form;
  • Pregnant or lactating women;
  • Other conditions deemed unsuitable for inclusion in the study by the investigator.

Treatment and study plan

PD-1 / PD-L1 monoclonal antibody

Drug

Patients with advanced breast cancer who have already received and continue to use immunotherapy, or are planned to receive immunotherapy, and have been recommended for radiotherapy after evaluation by a multidisciplinary team (MDT) in the early stage and have completed radiotherapy, are registered and followed up in this study.

Other names: Radiotherapy.

Primary outcomes

  1. Progression-Free Survival

    Time frame: 24 months

    According to RECIST 1.1 criteria:Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).

Study contacts

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

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 15, 2025
Registry last updated
Jun 9, 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.

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