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NCT05301010
Clinical Trial to Assess Efficacy and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients
Phase 3 trial testing Faceptor in Breast Cancer Metastatic in 128 participants. Completed in 19 February 2021.
19 February 2021
Quick facts
| Lead sponsor | Nanogen Pharmaceutical Biotechnology Joint Stock Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 2 February 2018 |
| Primary completion | 19 February 2021 |
| Estimated completion | 19 February 2021 |
| Sites | 2 locations across Vietnam |
Drugs / interventions tested
- Faceptor — full drug profile →
- Herceptin (trastuzumab) — full drug profile →
- Docetaxel (Docetaxel) — full drug profile →
Conditions studied
- Breast Cancer Metastatic — all drugs for Breast Cancer Metastatic →
- Breast Cancer Recurrent — all drugs for Breast Cancer Recurrent →
- Breast Cancer Female — all drugs for Breast Cancer Female →
Sponsor
Nanogen Pharmaceutical Biotechnology Joint Stock Company — full company profile →
Who can join
Adults 18 to 65, female only, with Breast Cancer Metastatic or Breast Cancer Recurrent. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05301010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Faceptor
Trials testing the same drug.
- NCT05301530 — Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Brea · Phase 1 · completed
Other recruiting trials for Breast Cancer Metastatic
Currently open trials in the same condition.
- NCT07292168 — A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Ex · Phase 1, PHASE2 · recruiting
- NCT06616987 — Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer · Phase 2 · recruiting
- NCT06750484 — Trial of Trastuzumab Deruxtecan in Previously Treated HER2 · Phase 2 · recruiting
- NCT06784921 — To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Pa · recruiting
- NCT07154563 — Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Ca · recruiting
Other Nanogen Pharmaceutical Biotechnology Joint Stock Company trials
Trials by the same sponsor.
- NCT05636891 — Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Pati · Phase 1 · completed
- NCT04922788 — Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19 · Phase 3 · completed
- NCT04683484 — A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers · Phase 1, PHASE2 · unknown
- NCT05585645 — A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in · Phase 3 · completed
- NCT05301530 — Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Brea · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05301010 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanogen Pharmaceutical Biotechnology Joint Stock Company
- Last refreshed: 27 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05301010.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing