Comparing DP303c and trastuzumab emtansine for advanced HER2-positive breast cancer

A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer

This study is testing a new injection called DP303c to see if it works better than trastuzumab emtansine for people with advanced HER2-positive breast cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: trastuzumab, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06313086 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of DP303c injection compared to trastuzumab emtansine in patients with HER2-positive advanced breast cancer. It is a multi-centre, randomized, open-label, controlled phase III study where patients will receive either DP303c at 3.0 mg/kg or trastuzumab emtansine at 3.6 mg/kg every three weeks. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, death, or other reasons for discontinuation occur.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable locally advanced or metastatic HER2-positive breast cancer who have previously received trastuzumab and taxanes.

Not a fit: Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy or have other malignancies within the last three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that may improve outcomes for patients with HER2-positive advanced breast cancer.

How similar studies have performed: Other studies have shown success with similar approaches in treating HER2-positive breast cancer, indicating a promising avenue for further exploration.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions HER2-positive Breast Cancer