NCT05301530

Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients.

Randomized, Single-blind, Multicenter, Parallel Group Clinical Trial to Assess Pharmacokinetic Parameters, Safety of NNG-TMAB (Trastuzumab) in Combination With Docetaxel on Recurrent or Metastatic Breast Cancer Patients With Positive HER2.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 50 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. Primary endpoint is serum peak concentrations (Cmax), area under the curve from 0 to t (AUC0-t). This trial is intended to assess the biosimilarity of pharmacokinetic parameters, safety between Faceptor (experimental drug) and Herceptin (reference).

Conditions

• Breast Cancer Metastatic
• Breast Cancer Female
• Breast Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Faceptor	NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.
DRUG	Herceptin	Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.
DRUG	Docetaxel	The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.

Timeline

• Start date: 2019-05-27
• Primary completion: 2020-08-31
• Completion: 2021-02-19
• First posted: 2022-03-29
• Last updated: 2022-03-29

Locations

2 sites across 1 country: Vietnam