Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients

Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) is an antibody-conjugated drug. Results from the phase I safety, tolerability and pharmacokinetic trial of ARX788 single drug in Chinese patients with advanced HER2 breast cancer indicated a good safety of the test drug, and responses to anti-tumor therapy were observed in the target dose group. Phase II clinical trial is being carried out gradually. This trial is designed to observe the effectiveness and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment

Trial Details

NCT ID
NCT04983121
Phase
PHASE2
Sponsor
Shengjing Hospital
Status
RECRUITING
Cancer Type
Ductal Carcinoma In Situ (DCIS) Breast Cancer
Interventions
  • Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788)
Locations (sample)
  • Shenyang, Liaoning, China|41.79222,123.43278

Key Eligibility Criteria

  • Female patients aged ≥ 18 but ≤ 75 years (The maximal age of the subjects enrolled in the Phase 3 study of pyrotinib is 75 years old, and there is …
  • Diagnosis of breast cancer meets the following criteria: Histologically confirmed invasive breast cancer; Tumor staging: Stage II-III patients who …
  • HER2-positive breast cancer pathologically confirmed is defined as Immunohistochemical method (IHC3+) or FISH+;
  • Eastern Cooperative Oncology Group (ECOG) level 0-1;

For full eligibility, visit ClinicalTrials.gov.

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