Actively Recruiting
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-05-10
442
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
CONDITIONS
Official Title
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate in the study and sign the informed consent
- 18 years of age or older
- Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology
- Confirmed HER2-positive status defined as IHC 3+ or IHC 2+ with ISH positive
- Previously received regimens containing trastuzumab and taxanes at the advanced stage
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function
- Life expectancy of at least 3 months
- Female and male patients of childbearing age must agree to use adequate contraceptive measures during the study period
You will not qualify if you...
- Previous treatment with tubulin inhibitor-loaded HER2 ADC therapy
- History of any other malignant tumors within the past 3 years
- Uncontrollable serous effusion within 14 days before randomization requiring frequent drainage or medical intervention
- Known contraindication to the study drugs
- Not recovered from adverse reactions of previous anti-tumor treatments to Grade 1 or baseline
- Grade 2 or higher peripheral nephropathy during previous systemic anti-tumor treatment
- Received immunotherapy, macromolecular targeted therapy, or other anti-tumor biological therapy within 4 weeks before randomization
- Received endocrine therapy, cytotoxic chemotherapy, or small molecular targeted therapy within 2 weeks before randomization
- Received traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization
- Major organ surgery (excluding needle biopsy) within 28 days before randomization
- Untreated or unstable brain metastasis, spinal cord metastasis, or cancerous meningitis
- Cumulative anthracycline dosage reached
- History of left ventricular ejection fraction below 40%, symptomatic congestive heart failure
- Serious or uncontrolled cardiovascular disease
- History of non-infectious interstitial lung disease or pneumonitis requiring steroid therapy
- Current ocular diseases requiring medication or surgery, or unwillingness to stop using contact lenses during the study
- Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization
- Other conditions interfering with study participation or affecting study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here