Actively Recruiting
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2026-02-25
540
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs. THP as first-line treatment for HER2-positive unresectable, locally advanced or metastatic breast cancer.
CONDITIONS
Official Title
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Male or female participants aged 18 years or older
- Confirmed HER2-positive unresectable, locally advanced, or metastatic breast cancer
- Documented hormone receptor status (positive or negative) in metastatic setting
- No prior chemotherapy or HER2-targeted therapy for advanced breast cancer (except allowed endocrine therapy)
- ECOG performance status of 0 or 1
- Evidence of disease progression after last systemic therapy
- Life expectancy of at least 12 weeks
- At least one measurable lesion suitable for repeated measurement
- Left ventricular ejection fraction (LVEF) 50% or higher within 28 days before randomization
- Adequate organ and bone marrow function based on defined laboratory values
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during and for 6 months after treatment
You will not qualify if you...
- Prior treatment with camptothecin-containing antibody-drug conjugates
- Uncontrolled or significant cardiovascular diseases including recent heart attack or symptomatic heart failure
- History of serious thromboembolic events within specified timeframes
- Symptomatic or uncontrolled arrhythmias or prolonged QT interval
- Non-infectious pneumonitis requiring corticosteroids or other significant lung diseases
- Recent anticancer therapies or major surgery within specified washout periods
- Use of immunosuppressive medications within 14 days before first dose, except specific low-dose corticosteroids
- Known symptomatic central nervous system metastases or leptomeningeal carcinoma
- Unhealed adverse events from prior cancer treatments above grade 1 except certain stable conditions
- Tumor invading vital organs or tissues
- Recent life-threatening bleeding or effusions requiring intervention
- High risk of bleeding from varices or portal hypertension
- Unhealed gastrointestinal obstructions or certain gastrointestinal diseases
- Biliary obstruction without successful treatment
- Severe liver disease or malnutrition requiring intravenous nutrition
- Active infections including HIV, hepatitis B or C, tuberculosis, or syphilis
- History of immunodeficiency or organ transplantation
- Pregnant or breastfeeding women or those planning pregnancy
- Contraindications or known allergies to study drugs
- Other active malignancies within 3 years except certain skin or thyroid cancers
- Participation in other interventional clinical studies
- Substance abuse or medical conditions interfering with study participation
- Psychiatric or social conditions preventing compliance or informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
X
Xiaodong Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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