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Placebo, Trastuzumab, Docetaxel
This combination uses trastuzumab to block HER2 signaling in cancer cells while docetaxel disrupts microtubule dynamics to inhibit cell division, with placebo as a control arm.
This combination uses trastuzumab to block HER2 signaling in cancer cells while docetaxel disrupts microtubule dynamics to inhibit cell division, with placebo as a control arm. Used for HER2-positive breast cancer (metastatic or early-stage), HER2-positive gastric cancer.
At a glance
| Generic name | Placebo, Trastuzumab, Docetaxel |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Monoclonal antibody + taxane chemotherapy combination |
| Target | HER2 (trastuzumab); tubulin (docetaxel) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, preventing growth signaling and triggering immune-mediated cell death. Docetaxel is a taxane chemotherapy that stabilizes microtubules and prevents their disassembly, leading to mitotic arrest and apoptosis. Together they provide complementary mechanisms targeting HER2-positive cancers.
Approved indications
- HER2-positive breast cancer (metastatic or early-stage)
- HER2-positive gastric cancer
Common side effects
- Neutropenia
- Anemia
- Nausea/vomiting
- Fatigue
- Peripheral neuropathy
- Cardiotoxicity (trastuzumab-related)
- Hypersensitivity reactions
Key clinical trials
- Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) (PHASE3)
- Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (PHASE3)
- 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)
- Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer (PHASE3)
- A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) (PHASE3)
- Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel (PHASE3)
- Thero2-01S22 in HER2-positive Breast Cancer (PHASE3)
- A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer (PHASE3)
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:
- Placebo, Trastuzumab, Docetaxel CI brief — competitive landscape report
- Placebo, Trastuzumab, Docetaxel updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI