DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
NCT06313086
Study Details
Design, interventions, and primary outcomes
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About This Study
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
Design
Study type: Interventional
Phases: Phase3
Allocation: Randomized
Intervention model: Parallel
Primary purpose: Treatment
Masking/blinding: None
Interventions / Regimen
- Drug: DP303c — intravenous injection
- Drug: trastuzumab emtansine — intravenous injection
Primary Outcomes
- Progression-free survival (PFS) by BIRC (Up to approximately 4 years)
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2024-03-13
Completion: 2028-02
Phase: PHASE3
Status: Recruiting
Start Date: 2024-03-13
Completion: 2028-02
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 442 (ESTIMATED)
Sex: ALL
Volunteers: false
Enrollment: 442 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Information
Study Contact:
Clinical Trials Information Group officer
86-0311-69085587
ctr-contact@cspc.cn
Xichun Hu, PhD
021-64175590
xchu2009@hotmail.com
Fudan University Shanghai Cancer Center
Interventions
- Drug: DP303c — intravenous injection
- Drug: trastuzumab emtansine — intravenous injection
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria:
* 1．Voluntarily agree to participate in the study and sign the informed consent;
* 2．Age≥18 years old;
* 3．Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology;
* 4．Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
* 5．Previously received regimens containing trastuzumab and taxanes at the advanced stage of disease.
* 6．The Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
* 7．Patients with adequate organ functions;
* 8．Life expectancy ≥ 3 months;
* 9．Female and male patients of childbearing age must agree to take adequate contraceptive measures during the entire study period.
Exclusion Criteria:
* 1\. Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy
* 2\. History of any other malignant tumors within three years
* 3\. With uncontrollable serous effusion within 14 days before randomization, which required frequent drainage or medical intervention.
* 4\. Known contraindication to the study drugs;
* 5\. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 or baseline (refer to NCI CTCAE 5.0);
* 6\. NCI-CTCAE 5.0 ≥Grade 2 peripheral nephropathy occurred during previous systemic anti-tumor treatment;
* 7\. Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization .
* 8\. Major organ surgery (excluding needle biopsy) within 28 days before randomization;
* 9\. Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
* 10.The cumulative amount of previous exposure to anthracyclines has reached the dosage;
* 11.History of LVEF \< 40%, symptomatic congestive heart failure (CHF),
* 12.Serious or uncontrolled cardiovascular disease;
* 13.History of (non-infectious) interstitial lung disease/pneumonitis requiring steroid hormone therapy;
* 14.Patients who currently have ocular diseases that require medication or surgical intervention; or unwilling to stop wearing contact lenses during the study.
* 15.Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization;
* 16.There are other circumstances that may interfere with the subject's participation in the study procedures or do not meet the subject's maximum benefit from participating in the study or affect the study results.