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

NCT07117864 | Recruiting

• 2 other identifiers: 24/376-4656NCC4774
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• brain progression-free survival

  brain progression-free survival

  At the end of Cycle 1(each cycle is 21 days)

Study Arms (1)

T-DXd concurrent brain radiotherapy

EXPERIMENTAL

T-DXd：5.4mg/kg ivgtt Q3w SRT/WBRT

Combination Product: T-DXd concurrent brain radiotherapy

Interventions

T-DXd concurrent brain radiotherapy COMBINATION_PRODUCT

T-DXd：5.4mg/kg ivgtt Q3w SRT/WBRT

T-DXd concurrent brain radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Tumor-Related Symptoms and Treatments
• Uncontrolled moderate to large pleural effusion, ascites, or pericardial effusion requiring repeated drainage;
• Imaging (CT or MRI) showing tumor invasion of major blood vessels, or cases deemed by the investigator as highly likely to cause fatal hemorrhage due to vascular invasion during the study period;
• Signs of meningeal irritation such as neck stiffness, seizures, or cognitive impairment, or confirmed leptomeningeal metastasis by imaging (CT or MRI) or lumbar puncture;
• Uncontrolled or symptomatic hypercalcemia (defined as ionized calcium \> 1.5 mmol/L, serum calcium \> 12 mg/dL, or albumin-corrected serum calcium \> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate treatment;
• Prior cranial radiotherapy;
• Prior treatment with trastuzumab deruxtecan (T-DXd).
• Comorbidities / Medical History
• History of other malignancies for which the patient received any systemic anti-cancer therapy or local treatment (including surgery or radiotherapy), except for adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;
• Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from such surgery (diagnostic biopsies and PICC line placement are permitted);
• Known or suspected autoimmune diseases, except for the following conditions:
• Hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy; Stable Type I diabetes mellitus with controlled blood glucose;
• Presence of interstitial lung disease (ILD), non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);
• HIV infection or known AIDS; active hepatitis (HBV defined as HBV-DNA ≥ 500 IU/mL; HCV defined as HCV-RNA above the lower limit of detection); concurrent HBV and HCV infection; autoimmune hepatitis;
• Severe infections within 4 weeks before first dose (e.g., bacteremia or severe pneumonia requiring hospitalization), or active infections requiring systemic antibiotic therapy of CTCAE grade ≥2 within 2 weeks before first dose, or unexplained fever \>38.5°C during screening or prior to first dose (fever deemed tumor-related may be eligible at the investigator's discretion); evidence of active tuberculosis within 1 year prior to first dose;

Sponsors & Collaborators

• QIAO LI: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qiao Li, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Qiao Li, MD

CONTACT

86-87788820; liqiaopumc@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-07

Locations

CN (1)