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Clinical Trials in China / NCT07466927
Starting soon Phase 2

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases

NCT07466927 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2026-03-15
Last updated
2026-03-12

Condition(s) studied

HER2-negative Breast Cancer

Investigational drug(s) / intervention(s)

SHR-A1811 →SKB264 →Pembrolizumab →SHR-1316 →

SHR-A1811: A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.

SKB264: A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.

Pembrolizumab: PD-1 antibody, via intravenous (into the vein) infusion per protocol.

SHR-1316: PD-L1 antibody, via intravenous (into the vein) infusion per protocol.

Study summary

This is a prospective, open-label, phase II platform trial. The purpose of this study is to test the safety and effectiveness of multi-mode thermal therapy combined with immunotherapy in patients with HER2-negative breast cancer with liver metastases who had previously received systemic therapy

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Female patients aged ≥ 18 years; 2. Histologically confirmed HER2-negative invasive breast cancer (defined as: HER2 0 or 1+, or HER2 2+ with negative FISH result indicating no amplification); 3. Breast cancer with liver metastasis; 4. Patients who have received and failed ≥ 1 line of systemic therapy after diagnosis of recurrent or metastatic breast cancer, with documented disease progression: For HR+/HER2- advanced breast cancer: prior CDK4/6 inhibitor therapy in the advanced setting; For HR-/HER2- advanced breast cancer: at least one line of chemotherapy in the advanced setting; 5)At least one measurable lesion per RECIST 1.1 (not previously irradiated) other than the ablation target lesions; 6)Intrahepatic metastatic lesions: number ≤ 10, maximum diameter ≤ 4 cm, no vascular or bile duct invasion; 7)Adequate organ function, meeting the following criteria: 1. Laboratory hematology: HB ≥ 90 g/L (without transfusion within 14 days); ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; 2. Laboratory biochemistry: TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 5×ULN; 8) Expected survival ≥ 12 weeks; 9)Female subjects of childbearing potential must use a medically accepted contraceptive method during study treatment and for at least 3 months after the last dose of study drug. 10)Subjects have voluntarily agreed to participate in this study, signed the informed consent form, are compliant, and willing to comply with follow-up requirements. Exclusion Criteria: 1. Uncontrolled central nervous system (CNS) metastases, defined as symptomatic metastases or those requiring glucocorticoids or mannitol for symptom control. 2. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmia. 3. Received radiotherapy or surgical treatment for advanced HER2-negative breast cancer within 1 week prior to the first study drug administration or study procedure. 4. Pregnant or lactating patients. 5. Malignancy diagnosed within the past 3 years, except for cured basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix. 6. Significant comorbidities, including psychiatric disorders that, in the investigator's judgment, would adversely affect the patient's participation in the study. 7. History of gastrointestinal bleeding or definite gastrointestinal bleeding tendency within the previous 6 months, including esophageal varices at risk of bleeding, active local ulcerative lesions, or stool occult blood ≥ ++. Patients with stool occult blood (+) must undergo gastroscopy. 8. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment. 9. Urinalysis showing urine protein ≥ ++ or confirmed 24-hour urinary protein \> 1.0 g. 10. Hypertension that cannot be controlled within the normal range by antihypertensive therapy (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg). 11. Patients with allergic constitution, known hypersensitivity to any component of the study drugs, or hypersensitivity to other monoclonal antibodies. 12. Pre-existing thyroid dysfunction. 13. Any other conditions in which the investigator deems the patient unsuitable for participation in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Breast cancer institute of Fudan University Cancer Hospital Shanghai Shanghai Municipality

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07466927 on ClinicalTrials.gov ↗ ← All trials in China