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

NCT06975462 | Not Yet Recruiting Phase 2

• 1 other identifier: UH-SHR A1811 and radiotherapy
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

breast cancer; barin metastases

Outcome Measures

Primary Outcomes (1)

• The objective response rate of intracranial（IC-ORR）

  Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors

  2 years

Secondary Outcomes (4)

• Intracranial CNS Progression Free Survival(IC-PFS)

  2 years

• Progression Free Survival(PFS)

  2 years

• Overall survival(OS)

  3 years

• Adverse Events

  2 years

Study Arms (1)

SHR-A1811+radiotherapy

EXPERIMENTAL

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

Combination Product: SHR-A1811 and radiotherapy

Interventions

SHR-A1811 and radiotherapy COMBINATION_PRODUCT

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

SHR-A1811+radiotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer
• Age\>18 years.
• newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than 6.
• No more than four lines of previous advanced therapy
• Life expectancy of more than 3 months
• There were no known or suspected leptomeningeal brain metastases
• The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less
• 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
• 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

You may not qualify if:

• Leptomeningeal or hemorrhagic metastases
• previously used T-dxd
• Uncontrolled epilepsy
• 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.
• History of allergy to treatment regimens
• Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
• Inability to complete enhanced MRI

Sponsors & Collaborators

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jing Yao

CONTACT

13971139665; jeaneyph@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share