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

January 14, 2025 updated by: Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

September 10, 2028

Study Completion (Estimated)

September 10, 2028

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4908

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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