A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases

NCT ID: NCT06975462

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-01

Brief Summary

A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases

Conditions

Breast Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811+radiotherapy

SHR-A1811:4.8mg/kg radiotherapy:800cGY\*5

Group Type: EXPERIMENTAL

SHR-A1811 and radiotherapy

Intervention Type: COMBINATION_PRODUCT

SHR-A1811:4.8mg/kg radiotherapy: 800cGY\*5

Interventions

SHR-A1811 and radiotherapy

SHR-A1811:4.8mg/kg radiotherapy: 800cGY\*5

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer

2. Age>18 years.

3. newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than 6.

4. No more than four lines of previous advanced therapy

5. Life expectancy of more than 3 months

6. There were no known or suspected leptomeningeal brain metastases

7. The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less

8. The use of mannitol, bevacizumab, or hormone therapy was allowed before enrollment, but the dose was stable for at least a week without the need for an increment

9. Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) LVEF ≥ 50% QTcF < 480 ms INR≤1.5×ULN，APTT≤1.5×ULN 10.Signed the informed consent form prior to patient entry

Exclusion Criteria

1. Leptomeningeal or hemorrhagic metastases

2. previously used T-dxd

3. Uncontrolled epilepsy

4. Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.

5. History of allergy to treatment regimens

6. Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.

7. Inability to complete enhanced MRI

8. Not suitable for inclusion for specific reasons judged by sponsor -

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jing Yao

Role: CONTACT

jeaneyph@163.com

13971139665

Other Identifiers

UH-SHR A1811 and radiotherapy

Identifier Type: -

Identifier Source: org_study_id