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epirubicin - cyclophosphamide / docetaxel + trastuzumab
epirubicin - cyclophosphamide / docetaxel + trastuzumab is a anthracycline antibiotic/alkylating agent/taxane/monoclonal antibody Small molecule drug developed by GBG Forschungs GmbH. It is currently in Phase 3 development for Adjuvant treatment of node-positive breast cancer, Metastatic breast cancer with overexpression of HER2/neu.
Epirubicin is an anthracycline antibiotic that intercalates DNA strands, inhibiting topoisomerase II, while cyclophosphamide is an alkylating agent that cross-links DNA, causing cell death. Docetaxel is a taxane that stabilizes microtubules, preventing cell division, and trastuzumab is a monoclonal antibody that targets the HER2/neu receptor.
Epirubicin is an anthracycline antibiotic that intercalates DNA strands, inhibiting topoisomerase II, while cyclophosphamide is an alkylating agent that cross-links DNA, causing cell death. Docetaxel is a taxane that stabilizes microtubules, preventing cell division, and trastuzumab is a monoclonal antibody that targets the HER2/neu receptor. Used for Adjuvant treatment of node-positive breast cancer, Metastatic breast cancer with overexpression of HER2/neu.
At a glance
| Generic name | epirubicin - cyclophosphamide / docetaxel + trastuzumab |
|---|---|
| Sponsor | GBG Forschungs GmbH |
| Drug class | anthracycline antibiotic/alkylating agent/taxane/monoclonal antibody |
| Target | topoisomerase II/DNA/HER2/neu receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Epirubicin and cyclophosphamide work synergistically to induce DNA damage and apoptosis in rapidly dividing cancer cells. Docetaxel further inhibits cell division by stabilizing microtubules, leading to cell cycle arrest and apoptosis. Trastuzumab targets the HER2/neu receptor, which is overexpressed in certain breast cancers, and induces antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
Approved indications
- Adjuvant treatment of node-positive breast cancer
- Metastatic breast cancer with overexpression of HER2/neu
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Fatigue
- Nausea and vomiting
Key clinical trials
- A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer (PHASE3)
- PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial (PHASE2)
- Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer (PHASE2, PHASE3)
- Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer (PHASE2)
- A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (PHASE3)
- Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer (PHASE3)
- Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer (PHASE2)
- Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (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:
- epirubicin - cyclophosphamide / docetaxel + trastuzumab CI brief — competitive landscape report
- epirubicin - cyclophosphamide / docetaxel + trastuzumab updates RSS · CI watch RSS
- GBG Forschungs GmbH portfolio CI
Frequently asked questions about epirubicin - cyclophosphamide / docetaxel + trastuzumab
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Related
- Drug class: All anthracycline antibiotic/alkylating agent/taxane/monoclonal antibody drugs
- Target: All drugs targeting topoisomerase II/DNA/HER2/neu receptor
- Manufacturer: GBG Forschungs GmbH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of node-positive breast cancer
- Indication: Drugs for Metastatic breast cancer with overexpression of HER2/neu
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