Clinical Trial to Assess Efficacy and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients.
Status:
Completed
Trial end date:
2021-02-19
Target enrollment:
Participant gender:
Summary
Targeted therapy in the treatment of breast cancer targets HER2 receptor (Human Epidermal
growth factor Receptor). HER2 receptor plays an important role in cell growth and
differentiation (5). However, when HER2 overexpresses, it may lead to cancer. HER2 positive
malignance exacerbates pathology and worsens clinical outcome, such as shortened overall
survival (OS) compared with non-HER2 overexpression patients (6), (7). About 20-30%
overexpression HER2/neogene breast cancer patients and patients having HER2 overexpression
tumor have disease progression and poor prognosis in metastatic process (8), (9).
Currently, targeted therapeutic, which attaches to the HER2 receptor, inhibiting the growth
of cancer cells has been approved. One of these products is Trastuzumab.
The study processed on 128 females aged between 18 and 65, recurrent or metastatic breast
cancer patients with positive HER2.
The subjects were randomly distributed in 2 groups as NNG-TMAB + docetaxel or Herceptin® +
docetaxel, in blocks of 4 in a 1: 1 ratio (NNG-TMAB: Herceptin®). In each block of 4 will be
2 patients in the experimental group and 2 patients in the control group
Primany endpoints is Overall Response Rate (ORR) according to RECIST 1.1. ORR includes
Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an
Independent Tumor Evaluation Board (ITEB).
This trial is intended to assess the biosimilarity of efficacy and safety between NNG-TMAB
(Trastuzumab) and Herceptin® in combination with Docetaxel on recurrent or metastatic breast
cancer patients with positive HER2.
Phase:
Phase 3
Details
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company