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Real-world efficacy and safety of T-DXd monotherapy or in combination with radiotherapy and endocrine therapy in breast cancer patients with HER2-positive or HER2-low brain metastases.

Real-world efficacy and safety of T-DXd monotherapy or in combination with radiotherapy and endocrine therapy in breast cancer patients with HER2-positive or HER2-low brain metastases.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110848
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-10-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Brain Metastases

Interventions

T-DXd combined with radiotherapy +/- ET group:None
T-DXd monotherapy or T-DXd + ET group:None

Sponsors

Army Characteristic Medical Center, People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female breast cancer patients aged >=18 years; 2.Pathologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH–) breast cancer; 3.Radiologically confirmed presence of brain metastases; 4.Received at least one cycle of T-DXd treatment; 5.Complete follow-up and imaging data available for efficacy evaluation.

Exclusion criteria

Exclusion criteria: 1.History of concurrent other malignant tumors; 2.Lack of efficacy or safety follow-up data during treatment; 3.Severe underlying diseases that preclude evaluation of treatment impact.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;—

Secondary

MeasureTime frame
Disease Control Rate;—

Countries

China

Contacts

Public ContactXu Yan

Army Characteristic Medical Center, People's Liberation Army

xy931@163.com+86 15923100038

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026