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Trastuzumab Injectable Solution
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 metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings).
At a glance
| Generic name | Trastuzumab Injectable Solution |
|---|---|
| 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 metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings)
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Infusion reactions
- Nausea
- Diarrhea
- Fatigue
- Headache
Key clinical trials
- A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (PHASE1)
- A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer (PHASE3)
- A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer (PHASE3)
- Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors (PHASE1)
- Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (NA)
- PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer (PHASE2)
- Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (PHASE1)
- MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (PHASE1)
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 Solution CI brief — competitive landscape report
- Trastuzumab Injectable Solution updates RSS · CI watch RSS
- Spanish Breast Cancer Research Group portfolio CI