A Prospective, Multicenter, Observational Cohort Study to... | NCT06839547

Studies
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.

NCT06839547

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Advanced Breast Cancer Brain Metastasis

Interventions

Radiotherapy + Novel Anti-tumor Drug

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Sep 10, 2028Estimated

Completion Date

Sep 10, 2028Estimated

First Submitted Date

Feb 18, 2025

First Submission Date that Met QC Criteria

Feb 18, 2025

First Posted Date

Feb 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2026

Last Update Posted Date

Jun 10, 2026Actual

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy + Novel Anti-tumor Drug	Drug	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.] Radiotherapy

Measure	Description	Time Frame
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.	24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include:

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.
Patients with a traceable medical history during the treatment period.
Patients who are able to sign the informed consent form to participate in the study.

Exclusion Criteria:

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.
Other situations deemed by the investigator as unsuitable for inclusion in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study 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.].

Sampling Method

Non-Probability Sample