Actively Recruiting
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
Led by Fudan University · Updated on 2025-09-19
48
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histologically or cytologically confirmed breast cancer
- Unresectable locally advanced or metastatic breast cancer
- Pathologically confirmed HER2-positive breast cancer (IHC 3+ or IHC 2+ with FISH positive)
- Prior treatment including trastuzumab deruxtecan (T-DXd), trastuzumab (or biosimilar), and taxane
- Documented disease progression or unacceptable toxicity after last therapy for advanced disease
- ECOG performance status of 0 to 2 with life expectancy greater than 3 months
- At least one measurable target lesion per RECIST v1.1
- Adequate organ and bone marrow function based on blood counts, liver, kidney, coagulation, heart function, and ECG
- Voluntary agreement to participate by signing informed consent and willingness to comply with follow-up
You will not qualify if you...
- Meningeal metastases confirmed by MRI or lumbar puncture
- Spinal cord compression or active central nervous system metastases requiring treatment
- Uncontrolled third-space fluid accumulation such as significant pleural effusion
- Prior treatment with inetetamab or any TROP-2 antibody-drug conjugate
- Receipt of other cancer therapies within 2 weeks before study treatment
- Concurrent treatment with any other anti-cancer therapy
- Known allergy to study drugs or prior discontinuation of trastuzumab due to toxicity
- Severe or uncontrolled cardiac conditions including heart failure class 3 or 4, unstable angina, recent heart attack, severe arrhythmia, or low heart function during prior trastuzumab therapy
- Severe concomitant diseases posing safety risks or interfering with study completion
- Unresolved toxicity from prior cancer therapy above grade 1 except alopecia or pigmentation
- History of other cancers within 5 years except certain treated skin or thyroid cancers
- History of immunodeficiency including HIV or active hepatitis
- Known neurological or psychiatric disorders such as epilepsy or dementia
- Pregnant or breastfeeding females of childbearing potential without negative pregnancy test and contraception agreement
- Any condition making the patient unsuitable for the study in the investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
J
Juan Jin
CONTACT
H
Hongxia Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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