Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Trastuzumab

Docetaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Patients received a loading dose of Faceptor 8 mg/kg IV + docetaxel 75 mg/m\^2 IV on Cycle 1 followed by Faceptor 6 mg/kg IV + docetaxel 75 mg/m\^2 IV on the next 5 cycles (each cycle is 21 days)

Patients received a loading dose of Herceptin 8 mg/kg IV + docetaxel 75 mg/m\^2 IV on Cycle 1 followed by Herceptin 6 mg/kg IV + docetaxel 75 mg/m\^2 IV on the next 5 cycles (each cycle is 21 days)

NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.

Faceptor

Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.

Herceptin

The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.

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).

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.

Area under the curve from 0 to t (AUC0-t)

Area under the curve from 0 to ∞ (AUC0-∞)

Time for the drug to reach peak concentration (Tmax)

Frequency of adverse events, including clinical examination, vital signs and laboratory tests.

Spots Global Cancer Trial Database for faceptor

Every month we try and update this database with for faceptor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for faceptor

Every month we try and update this database with for faceptor cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for faceptor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.