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

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 assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

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 following evaluation by a multidisciplinary team (MDT) in the early stage and have completed radiotherapy, are registered and followed up in this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Progression-Free Survival

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).

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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