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

NCT07466927 | Not Yet Recruiting Phase 2

• 1 other identifier: SCHBCC-N0109
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HER2-negative Breast Cancer

Keywords

HER2-negative Breast Cancer; Multi-mode Thermal Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS based on Kaplan-Meier methodology will be defined as the time from randomization until the identification of disease progression or death, whichever occurs first. Subjects without disease progression or death at the time of analysis will be censored at the date of last disease evaluation.

  The observation period related to this endpoint is up to 12 months.

Secondary Outcomes (2)

• Objective response rate (ORR)

  The observation period related to this endpoint is up to 12 months.

• Overall Survival (OS)

  The observation period related to this endpoint is up to 2 years.

Study Arms (2)

HER2(0)

EXPERIMENTAL

Pembrolizumab + SKB264（Trop2 ADC）

Drug: SKB264; Drug: Pembrolizumab

HER2-low

EXPERIMENTAL

SHR1316(PD-L1 antibody) + SHR-A1811(HER2 ADC)

Drug: SHR-A1811; Drug: SHR-1316

Interventions

SHR-A1811 DRUG

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

HER2-low

SKB264 DRUG

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

HER2(0)

Pembrolizumab DRUG

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

HER2(0)

SHR-1316 DRUG

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

HER2-low

Eligibility Criteria

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

You may qualify if:

• Female patients aged ≥ 18 years;
• Histologically confirmed HER2-negative invasive breast cancer (defined as: HER2 0 or 1+, or HER2 2+ with negative FISH result indicating no amplification);
• Breast cancer with liver metastasis;
• 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:
• Laboratory hematology:
• HB ≥ 90 g/L (without transfusion within 14 days); ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L;
• 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.
• )Subjects have voluntarily agreed to participate in this study, signed the informed consent form, are compliant, and willing to comply with follow-up requirements.

You may not qualify if:

• Uncontrolled central nervous system (CNS) metastases, defined as symptomatic metastases or those requiring glucocorticoids or mannitol for symptom control.
• History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmia.
• Received radiotherapy or surgical treatment for advanced HER2-negative breast cancer within 1 week prior to the first study drug administration or study procedure.
• Pregnant or lactating patients.
• Malignancy diagnosed within the past 3 years, except for cured basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix.
• Significant comorbidities, including psychiatric disorders that, in the investigator's judgment, would adversely affect the patient's participation in the study.
• 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.
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment.
• Urinalysis showing urine protein ≥ ++ or confirmed 24-hour urinary protein \> 1.0 g.
• Hypertension that cannot be controlled within the normal range by antihypertensive therapy (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg).
• Patients with allergic constitution, known hypersensitivity to any component of the study drugs, or hypersensitivity to other monoclonal antibodies.
• Pre-existing thyroid dysfunction.
• Any other conditions in which the investigator deems the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

zhimin shao, MD

CONTACT

86-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)