Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taxotere · 1 trial · 1 indication
DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.
| Arm | Type | Description |
|---|---|---|
| TC+H | EXPERIMENTAL | On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel (Taxotere) 75 mg/m2 IV (over 1 hour), plus cyclophosphamide (Cytoxan) 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. |
| Name | Type | Description |
|---|---|---|
| Taxotere | DRUG | On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years. |
| Cytoxan | DRUG | On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years. |
| Herceptin | DRUG | On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years. |
Inclusion Criteria: A woman will be eligible for inclusion in this study if she meets all of the following criteria: * Has HER2+ (IHC staining of 3+ \[uniform, intense membrane staining of \>30% of invasive tumor cells\], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio \[HER2 g...
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Taxotere is a small molecule oncology drug used in the treatment of breast cancer. It is being studied in early stage breast cancer, specifically in a clinical trial evaluating adjuvant TC plus Herceptin. The drug is currently in Phase 2 clinical development for this indication.
Taxotere is developed by McKesson Corporation, a company traded on the New York Stock Exchange under the ticker MCK. McKesson is the developer of the drug for the breast cancer indication.
Taxotere is in Phase 2 clinical development for breast cancer. It is an investigational drug and has not been approved for this use. The drug is being studied in a completed Phase 2 clinical trial.
Taxotere is associated with one clinical trial, NCT00493649, titled "Adj TC + Herceptin Early Stage Breast Cancer." This Phase 2 trial enrolled 493 female participants aged 18 years and older in the United States. The trial has been completed.
Taxotere is a brand name for the chemotherapy drug docetaxel. It is a small molecule used in oncology. The drug is being studied in combination with Herceptin for early stage breast cancer in a Phase 2 clinical trial.