A Phase 3 interventional study of Faceptor and Herceptin in Breast Cancer Metastatic, Breast Cancer Recurrent and Breast Cancer Female, sponsored by Nanogen Pharmaceutical Biotechnology Joint Stock Company. Completed at 2 sites in Vietnam. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-27.
Sponsored by Nanogen Pharmaceutical Biotechnology Joint Stock Company · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 128 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Nanogen Pharmaceutical Biotechnology Joint Stock Company is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: Faceptor · Drug: Docetaxel
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)
Drug: Herceptin · Drug: Docetaxel
NNG-TMAB (trastuzumab) 150 mg, 440 mg, lyophilized power for injection, manufacturered by Nanogen Pharmaceutical Biotechnology JSC.
Also known as: NNG-TMAB, Trastazumab
Herceptin (trastuzumab) 150mg, 440mg, powder for concentrate for solution, manufactured by Roche.
Also known as: Trastazumab
The drug Docetaxel in this study has the brand name Taxotere manufactured by Sanofi company.
Also known as: Taxotere
Overall Response Rate (ORR) according to RECIST 1.1 after 6 cycles
ORR includes Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).
Time frame: at the end of cycle 6 (each cycle is 21 days)
Overall Response Rate (ORR) according to RECIST 1.1 at the end of study
ORR includes Complete Response Rate and Partial Response Rate. ORR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).
Time frame: baseline through end of study (up to 128 days)
Progressive Disease Rate (PDR) according to RECIST 1.1
Progressive Disease Rate (PDR). PDR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).
Time frame: PDR will be evaluated every 3 cycles (each cycle is 21 days) through the end of study (up to 128 days)
Stable Disease Rate (SDR) according to RECIST 1.1
Stable Disease Rate (SDR). SDR will be independently evaluated by an Independent Tumor Evaluation Board (ITEB).
Time frame: SDR will be evaluated every 3 cycles (each cycle is 21 days) through the end of study (up to 128 days)
Progression-free survival (PFS) according to RECIST 1.1
Progression-free survival (PFS) was defined as the time between the date patient signed the Informed Consent Form (ICF) and the date of disease progression or death from any cause.
Time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to 128 days (6 cycles - each cycle is 21 days))
Evaluate the patient's quality of life
Quality of life of patients according to the EORTC QLQ-C30 questionnaire combined with EORTC QLQ-BR23 at week 24. All scores were linearly transformed to a 0 to 100 scale, according to international guidelines before assessment. A high or healthy level of functioning is represented by a high functional score. A high QOL is represented by a high score for global health status or QOL. More severe symptoms or problems are represented by high symptom scores or items. (i) EORTC QLQ-C30: is designed to measure cancer patients' physical, psychological and social functions. (ii) EORTC QLQ-BR23: is a breast-specific module that comprises of 23 questions.
Time frame: At week 24th
Anti-drug antibody evaluation
Percentage of participants with positive Anti-drug antibody
Time frame: At baseline,after 3 cycles of treatment, after 6 cycles of treatment (each cycle is 21 days)
Rate of AE and SAE occurence
Frequency of adverse events, including clinical examination, vital signs and laboratory tests
Time frame: up to 128 days (6 cycles - each cycle is 21 days)
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Nanogen Pharmaceutical Biotechnology Joint Stock Company