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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Clinical Trials Information Group officer
• Email: ctr-contact@cspc.cn
• Phone: 86-0311-69085587

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic breast cancer

  This trial tests whether GQ1005 works as well as T-DM1 for adults with HER2-positive unresectable or metastatic breast cancer who have already had trastuzumab and taxane.

  Recruiting at 70 sites Phase 3 GeneQuantum Healthcare (Suzhou) Co., Ltd. · Bengbu, Anhui and 69 other locations · NCT07673029

• Trastuzumab Rezetecan Neoadjuvant Therapy for HER2-Positive Breast Cancer

  This trial tests whether adding trastuzumab rezetecan after an initial THP treatment helps patients with HER2-positive breast cancer decide if they should switch therapies based on response.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07647263

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• BL-M07D1 plus pertuzumab vs standard therapy in first-line HER2-positive breast cancer

  A Phase 3 trial tests whether adding BL-M07D1 to pertuzumab is as good as or better than docetaxel plus trastuzumab and pertuzumab in patients with newly diagnosed, unresectable or metastatic HER2-positive breast cancer.

  Recruiting at 2 sites Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT07518173

• RO7771950 versus tucatinib with trastuzumab and capecitabine for HER2-positive locally advanced or metastatic breast cancer

  This test will see if RO7771950 combined with trastuzumab and capecitabine works better than tucatinib combined with the same drugs for people with HER2-positive locally advanced or metastatic breast cancer.

  Recruiting at 219 sites Phase 2/3 Hoffmann-La Roche · Huntsville, Alabama and 218 other locations · NCT07413939

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.