HER2-negative Breast CancerPhase 2NCT07466927
Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases
A Phase 2 study testing SHR-A1811, SKB264 and Pembrolizumab in people with HER2-negative Breast Cancer, run by Fudan University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-negative Breast Cancer
- What is being tested?
- SHR-A1811, SKB264 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 15 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, MD, 86-21-64175590, Zhimingshao@yahoo.com
Zhimin shao, MD
About this study
Official title: 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
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
Read the 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.
- Conditions
- HER2-negative Breast Cancer
- Being tested
- SHR-A1811, SKB264, Pembrolizumab, SHR-1316
- Keywords
- HER2-negative Breast Cancer, Multi-mode Thermal Therapy, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
SKB264Drug
A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
PembrolizumabDrug
PD-1 antibody, via intravenous (into the vein) infusion per protocol.
SHR-1316Drug
PD-L1 antibody, via intravenous (into the vein) infusion per protocol.
| Study group | Role | What they receive |
|---|---|---|
| HER2(0) | Experimental | Pembrolizumab + SKB264（Trop2 ADC） Receives: Drug: SKB264; Drug: Pembrolizumab |
| HER2-low | Experimental | SHR1316(PD-L1 antibody) + SHR-A1811(HER2 ADC) Receives: Drug: SHR-A1811; Drug: SHR-1316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The observation period related to this endpoint is up to 12 months.
Secondary outcomes (2)
Objective response rate (ORR)
Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined per protocol.
Measured: The observation period related to this endpoint is up to 12 months.
Overall Survival (OS)
Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
Measured: The observation period related to this endpoint is up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466927
- Sponsor's protocol ID
- SCHBCC-N0109
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07466927
- Acronym / sponsor ID
- SCHBCC-N0109
- Conditions
- HER2-negative Breast Cancer
- Keywords
- HER2-negative Breast Cancer, Multi-mode Thermal Therapy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2(0) | Experimental | Drug: SKB264, Drug: PembrolizumabPembrolizumab + SKB264（Trop2 ADC） |
| HER2-low | Experimental | Drug: SHR-A1811, Drug: SHR-1316SHR1316(PD-L1 antibody) + SHR-A1811(HER2 ADC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1811A HER2-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | HER2-low |
| SKB264A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | HER2(0) |
| PembrolizumabPD-1 antibody, via intravenous (into the vein) infusion per protocol. | Drug | HER2(0) |
| SHR-1316PD-L1 antibody, via intravenous (into the vein) infusion per protocol. | Drug | HER2-low |
Primary outcome
Progression Free Survival (PFS)
Time frame: The observation period related to this endpoint is up to 12 months.
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.
2 secondary outcomes
Objective response rate (ORR)
Time frame: The observation period related to this endpoint is up to 12 months.
Overall Survival (OS)
Time frame: The observation period related to this endpoint is up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811, SKB264 and Pembrolizumab in people with HER2-negative Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhimin shao, MD (86-021-64175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: The observation period related to this endpoint is up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.