Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Female patients aged ≥18 and ≤75 years with histologically confirmed breast cancer.

• ECOG performance status of 0 to 2.

• HER2-positive or HER2-low invasive breast cancer, defined as:

• HER2-positive: IHC 3+ or IHC 2+ with FISH amplification; HER2-low: IHC 2+ without FISH amplification, or IHC 1+.

• Confirmed diagnosis of breast cancer brain metastases.

• Patients may have received prior chemotherapy (from first-line to multiple lines), HER2-targeted therapy (monoclonal antibodies), endocrine therapy, and immunotherapy.

• Adequate organ function as defined below:

• Hematology:

• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L (no blood transfusion within 14 days prior to first dose); Hemoglobin (Hb) ≥ 80 g/L;

• Serum biochemistry:

• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN;

• Cardiac function:

• Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 45%.

• Subjects must voluntarily participate in the study and provide signed informed consent.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Qiao Li, MD
liqiaopumc@qq.com
86-87788820
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 40
Treatments
Experimental: T-DXd concurrent brain radiotherapy
T-DXd:5.4mg/kg ivgtt Q3w SRT/WBRT
Related Therapeutic Areas
Sponsors
Leads: QIAO LI

This content was sourced from clinicaltrials.gov