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Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases | Clinical Trials | Clareo Health

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

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases: A Prospective, Open-label, Phase II Trial

NCT07466927•Fudan University

View on ClinicalTrials.gov

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

Detailed Description

This is a prospective, open-label, phase II trial. The purpose of this study is to test the safety and effectiveness of multi-mode thermal therapy combined with immunotherapy in patients with advanced breast cancer who had previously received systemic therapy. The primary endpoint is progression free survival. Previous studies have shown that multi-mode thermal therapy can elicit systemic anti-tumor immune responses and sensitize immunity. To further validate these findings, we have designed this study to enroll HER2-negative patients who have progressed after conventional treatments (including chemotherapy, immunotherapy, ADC, etc.), with the aim of further investigating the clinical feasibility of multi-mode thermal therapy combined with immunotherapy and ADC therapy in patients with liver metastases in HER2-negative breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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).
+3 more criteria

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 15, 2026

Primary Completion Date

January 15, 2028

Completion Date

January 15, 2029

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

HER2-negative Breast Cancer

Interventions

SHR-A1811

DRUG

SKB264

DRUG

Pembrolizumab

DRUG

SHR-1316

DRUG

Contacts

zhimin shao, MD

CONTACT

86-021-64175590 zhimingshao@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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