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Trastuzumab Injectable Product
Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death.
Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death. Used for HER2-positive early-stage breast cancer (adjuvant therapy), HER2-positive metastatic breast cancer.
At a glance
| Generic name | Trastuzumab Injectable Product |
|---|---|
| Also known as | Herceptin |
| Sponsor | Spanish Breast Cancer Research Group |
| Drug class | HER2-targeted monoclonal antibody |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Trastuzumab targets human epidermal growth factor receptor 2 (HER2), a protein overexpressed in certain breast cancers. By binding to HER2, it prevents ligand-induced signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Approved indications
- HER2-positive early-stage breast cancer (adjuvant therapy)
- HER2-positive metastatic breast cancer
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Infusion reactions
- Nausea
- Diarrhea
- Headache
- Fatigue
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (PHASE3)
- A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer (PHASE2)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (PHASE3)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trastuzumab Injectable Product CI brief — competitive landscape report
- Trastuzumab Injectable Product updates RSS · CI watch RSS
- Spanish Breast Cancer Research Group portfolio CI