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.

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Breast Cancer Brain Metastasis
• Intervention / Treatment: Drug: Radiotherapy + Novel Anti-tumor Drug

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Fei Ma, Professor; Phone Number: 13910217780; Email: drmafei@126.com

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Cancer Hospital, Chinese Academy of Medical Sciences
    • Contact: MaFei Professor; Phone Number: 13910217780; Email: drmafei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.].

Description

Inclusion Criteria:

1. Males or females who are at least 18 years of age on the day of signing the informed consent form.
2. Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology.
3. 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.

4. 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.

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

Exclusion Criteria:

1. The subject has leptomeningeal metastasis.
2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
3. The subject has not signed the informed consent form.
4. Pregnant or breastfeeding women.
5. Other situations deemed by the investigator as unsuitable for inclusion in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 10, 2028
• Study Completion (Estimated): September 10, 2028

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Therapeutics; Radiotherapy
• Other Study ID Numbers: NCC5104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No