Clinical trial · Interventional
Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| humanized anti-HER2 antibody | Drug | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- combination agent group
- interventionNames
- Drug: humanized anti-HER2 antibody
- Drug: Vinorelbine
- type
- EXPERIMENTAL
- label
- single agent group
- description
- In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks
- interventionNames
- Drug: humanized anti-HER2 antibody
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- up to 24 weeks
- description
- according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * pathologic diagnosis breast cancer * HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria * Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3) * Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl) * Adequate cardiac function (LVEF\>50%). Normal electrocardiogram and absence of significant heart disease * age from 18 to 70y * Karnofsky performance score ≥ 60 * Life expectancy of greater than 3 months * Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. * signed ICF Exclusion Criteria: * prior exposure vinorelbine for breast cancer * prior exposure trastuzumab for breast cancer * Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment * use of any other investigational agents within the last 4 weeks before enrollment * symptomatic, central nervous system metastases * Hypersensitivity to trial medications * breastfeeding or pregnant
References
Publications (0)
Data not yet available