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trastuzumab and chemotherapy
trastuzumab and chemotherapy is a HER2-targeted monoclonal antibody + chemotherapy combination Small molecule drug developed by Comprehensive Support Project for Oncology Research. It is currently in Phase 3 development for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting), HER2-positive gastric cancer. Also known as: PTX, DTX, TC, AC.
Trastuzumab blocks HER2 signaling on cancer cells while chemotherapy drugs kill rapidly dividing cells, combining targeted and cytotoxic approaches.
Trastuzumab is an antibody that inhibits the receptor tyrosine-protein kinase erbB-2, a receptor protein-tyrosine kinase. It is used in combination with chemotherapy, such as XELOX, to treat conditions including Her-2 positive gastric cancer and breast cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | trastuzumab and chemotherapy |
|---|---|
| Also known as | PTX, DTX, TC, AC, EC |
| Sponsor | Comprehensive Support Project for Oncology Research |
| Drug class | HER2-targeted monoclonal antibody + chemotherapy combination |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Trastuzumab is a monoclonal antibody that binds to HER2 (human epidermal growth factor receptor 2) on cancer cell surfaces, blocking growth signals and triggering immune-mediated cell death. When combined with chemotherapy, the drugs work synergistically: trastuzumab provides targeted HER2 inhibition while chemotherapy agents cause direct DNA damage and cell death. This combination is particularly effective in HER2-positive cancers where HER2 overexpression drives tumor growth.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)
- HER2-positive gastric cancer
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Neutropenia
- Anemia
- Nausea and vomiting
- Infusion reactions
- Diarrhea
- Fatigue
Key clinical trials
- HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (EARLY_PHASE1)
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
- 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)
- Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
- A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (PHASE3)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (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 and chemotherapy CI brief — competitive landscape report
- trastuzumab and chemotherapy updates RSS · CI watch RSS
- Comprehensive Support Project for Oncology Research portfolio CI
Frequently asked questions about trastuzumab and chemotherapy
What is trastuzumab and chemotherapy?
How does trastuzumab and chemotherapy work?
What is trastuzumab and chemotherapy used for?
Who makes trastuzumab and chemotherapy?
Is trastuzumab and chemotherapy also known as anything else?
What drug class is trastuzumab and chemotherapy in?
What development phase is trastuzumab and chemotherapy in?
What are the side effects of trastuzumab and chemotherapy?
What does trastuzumab and chemotherapy target?
Related
- Drug class: All HER2-targeted monoclonal antibody + chemotherapy combination drugs
- Target: All drugs targeting HER2 (human epidermal growth factor receptor 2)
- Manufacturer: Comprehensive Support Project for Oncology Research — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive metastatic breast cancer
- Indication: Drugs for HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)
- Indication: Drugs for HER2-positive gastric cancer
- Also known as: PTX, DTX, TC, AC, EC
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing