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Also known as Trastuzumab, trastuzumab
Herceptin · 2 trials · 2 indications
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 0.04 mg/kg CpG 7909 |
| Cohort 2 | EXPERIMENTAL | 0.08 mg/kg CpG 7909 |
| Cohort 3 | EXPERIMENTAL | 0.12 mg/kg CpG 7909 Injection once weekly |
| Cohort 4 | EXPERIMENTAL | 0.16 mg/kg CpG 7909 |
| 1 | EXPERIMENTAL | Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose) |
| Name | Type | Description |
|---|---|---|
| 0.04 mg/kg CpG 7909 | DRUG | 0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| Herceptin® | DRUG | Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. |
| 0.08 mg/kg CpG 7909 | DRUG | 0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| 0.12 mg/kg CpG 7909 | DRUG | 0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| 0.16 mg/kg CpG 7909 | DRUG | 0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks |
| Herceptin | DRUG | Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks. |
| Sunitinib | DRUG | SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued. |
| Taxotere | DRUG | The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion. |
Inclusion Criteria: * Histologically confirmed breast cancer with metastases * Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry * Patients may have had up to three prior chemotherapy regimens for metastatic disease, w...
Herceptin is used for the treatment of breast cancer, specifically in patients with HER-2 positive advanced breast cancer. It is being studied in combination with other therapies, such as docetaxel and SU011248, to evaluate its efficacy in this patient population.
Herceptin targets HER-2, a protein that can promote the growth of cancer cells. It is a monoclonal antibody, classified under the -mab (antibody) target class, designed to bind to HER-2 receptors on breast cancer cells.
Herceptin is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the clinical development and commercialization of this oncology drug.
Herceptin is in Phase 1 clinical development for breast cancer. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and efficacy in patients.
Herceptin has been studied in clinical trials including NCT00043394, a Phase 2 study of CPG 7909 plus Herceptin in patients with metastatic breast cancer, and NCT00372424, a Phase 1 study of SU011248 in combination with docetaxel and trastuzumab in patients with advanced HER-2 positive breast cancer.
Yes, Herceptin is also known as trastuzumab. It is sometimes used in combination products, such as trastuzumab plus pertuzumab, which are also referred to as Herceptin combinations in clinical research.