HER2-positive, Unresectable, Locally Advanced or Metastatic Breast CancerPhase 2SHINE-HERNCT07182721
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
A Phase 2 study testing SKB264 Plus Inetetamab in people with HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer and SKB264, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
- What is being tested?
- SKB264 Plus Inetetamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 1 Feb 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female.
- Patients with histologically or cytologically confirmed breast cancer who meet the following criteria:
- Unresectable locally advanced or metastatic breast cancer.
- Pathologically confirmed HER2-positive breast cancer, regardless of hormone receptor (HR) status. HER2 positivity is defined as: IHC 3+, or IHC 2+ and FISH positive.
- Prior treatment for unresectable locally advanced or metastatic disease must have included the following anti-HER2 therapies: trastuzumab deruxtecan (T-DXd) and trastuzumab (or a trastuzumab biosimilar). Patients who received T-DXd and trastuzumab (or a biosimilar) in the (neo)adjuvant setting and experienced recurrence or metastasis during or within 12 months of completing therapy are eligible. Additionally, prior treatment regimens must have included a taxane.
- Documented disease progression or unacceptable toxicity after the last line of therapy for unresectable locally advanced or metastatic disease.
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- ECOG performance status of 0-2, with a life expectancy of > 3 months.
- At least one measurable target lesion according to RECIST v1.1 criteria.
- Adequate organ and bone marrow function, as defined below:
- Complete Blood Count: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- Liver Function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN. For patients with liver metastases, ALT and AST ≤ 5.0 × ULN.
- Renal Function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
- Coagulation Function: International Normalized Ratio (INR) ≤ 1.5 × ULN and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- Echocardiogram: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- 12-lead ECG: QT interval corrected by Fridericia's formula (QTcF) < 470 ms for females and < 450 ms for males.
- Voluntarily agrees to participate in the study by signing the informed consent form (ICF), and is willing and able to comply with follow-up procedures.
Who cannot join
- Meningeal metastases confirmed by MRI or lumbar puncture.
- Presence of spinal cord compression or clinically active central nervous system (CNS) metastases (defined as untreated or symptomatic metastases, or those requiring corticosteroids or anticonvulsants to control associated symptoms). Patients with previously treated brain metastases may be enrolled, provided they are clinically stable for at least 4 weeks, have no imaging evidence of progression, and at least 2 weeks have passed since the completion of brain radiotherapy and the discontinuation of corticosteroids or anticonvulsants for this indication.
- Presence of third-space fluid accumulation (e.g., significant pleural effusion) that cannot be controlled by drainage or other methods.
- Prior treatment with inetetamab or any TROP-2 antibody-drug conjugate (ADC).
- Receipt of whole-brain radiotherapy, chemotherapy, biologic targeted therapy, immunotherapy, surgery, endocrine therapy, or other investigational drugs within 2 weeks prior to the first dose of study treatment.
- Concurrent treatment with any other anti-cancer therapy.
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- Known history of hypersensitivity to any component of the study drugs. Permanent discontinuation of prior trastuzumab or its biosimilars due to any toxicity.
- Severe or uncontrolled cardiac disease requiring treatment, including:
- Congestive heart failure of New York Heart Association (NYHA) Class 3 or 4.
- Unstable angina pectoris uncontrolled by medication.
- Myocardial infarction within 6 months prior to the first dose of study treatment.
- Severe arrhythmia requiring medical treatment (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
- History of symptomatic congestive heart failure or a Left Ventricular Ejection Fraction (LVEF) <40% during previous trastuzumab therapy.
- Presence of any severe concomitant disease that, in the investigator's judgment, could jeopardize patient safety or interfere with study completion (e.g., uncontrolled severe diabetes, hypertension, autoimmune diseases), or any other condition deemed unsuitable for enrollment by the investigator.
- Toxicity from prior anti-cancer therapy that has not resolved to NCI-CTCAE v5.0 Grade ≤1 or baseline level (with the exception of Grade 2 alopecia, pigmentation, or other toxicities such as simple laboratory abnormalities that the investigator considers to pose no safety risk).
- History of other malignancies within the past 5 years, with the exception of curatively treated carcinoma in-situ, basal cell or squamous cell skin carcinoma, or papillary thyroid carcinoma after curative resection.
- History of immunodeficiency, including a positive HIV test, active Hepatitis B or C, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Known history of neurological or psychiatric disorders, including epilepsy or dementia.
- Female patients of childbearing potential who are pregnant or breastfeeding. A negative serum pregnancy test is required within 7 days prior to randomization. Patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 7 months after the last dose of study drug.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the 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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Hongxia Wang, 13524491606, whx365@126.com
About this study
Official title: A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.
- Conditions
- HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
- Being tested
- SKB264 Plus Inetetamab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264 Plus InetetamabDrug
SKB264: 5 mg/kg administered on Day 1 of each 2-week cycle. Inetetamab: an initial loading dose of 6 mg/kg is administered, followed by subsequent maintenance doses of 4 mg/kg. Dosing occurs on Day 1 of each 2-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| metastatic HER2-positive breast cancer | Experimental | Patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer previously treated with and refractory to T-DXd Receives: Drug: SKB264 Plus Inetetamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by investigator
ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
Measured: At baseline, at the time point of every 6 weeks, up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start30 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive, Unresectable, Locally Advanced or Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
- Investigators
- Hongxia Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182721
- Sponsor's protocol ID
- 2505320-11-2507
- Acronym
- SHINE-HER
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 15 Jul 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
- ClinicalTrials.gov ID
- NCT07182721
- Acronym / sponsor ID
- SHINE-HER / 2505320-11-2507
- Conditions
- HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 19 Sep 2025 (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, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic HER2-positive breast cancer | Experimental | Drug: SKB264 Plus InetetamabPatients with HER2-positive, unresectable, locally advanced or metastatic breast cancer previously treated with and refractory to T-DXd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years, male or female.
- Patients with histologically or cytologically confirmed breast cancer who meet the following criteria:
- ECOG performance status of 0-2, with a life expectancy of > 3 months.
- At least one measurable target lesion according to RECIST v1.1 criteria.
- Adequate organ and bone marrow function, as defined below:
Key exclusion criteria (20 listed)
- Meningeal metastases confirmed by MRI or lumbar puncture.
- Presence of spinal cord compression or clinically active central nervous system (CNS) metastases (defined as untreated or symptomatic metastases, or those requiring corticosteroids or anticonvulsants to control associated symptoms). Patients with previously treated brain metastases may be enrolled, provided they are clinically stable for at least 4 weeks, have no imaging evidence of progression, and at least 2 weeks have passed since the completion of brain radiotherapy and the discontinuation of corticosteroids or anticonvulsants for this indication.
- Presence of third-space fluid accumulation (e.g., significant pleural effusion) that cannot be controlled by drainage or other methods.
- Prior treatment with inetetamab or any TROP-2 antibody-drug conjugate (ADC).
- Receipt of whole-brain radiotherapy, chemotherapy, biologic targeted therapy, immunotherapy, surgery, endocrine therapy, or other investigational drugs within 2 weeks prior to the first dose of study treatment.
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 |
|---|---|---|
| SKB264 Plus InetetamabSKB264: 5 mg/kg administered on Day 1 of each 2-week cycle. Inetetamab: an initial loading dose of 6 mg/kg is administered, followed by subsequent maintenance doses of 4 mg/kg. Dosing occurs on Day 1 of each 2-week cycle. | Drug | metastatic HER2-positive breast cancer |
Primary outcome
ORR by investigator
Time frame: At baseline, at the time point of every 6 weeks, up to 1 years
ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
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 15 Jul 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.
Hongxia Wang principal investigator
Fudan University
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 SKB264 Plus Inetetamab in people with HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer and SKB264, 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 16 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 Juan Jin (15996290233, medjinjuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR by investigator (time frame: At baseline, at the time point of every 6 weeks, up to 1 years). 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 15 Jul 2026.