Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taxotere · 2 trials · 1 indication
PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng\*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.
Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
Mean AUC24\_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Sunitinib malate | DRUG | Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel) |
| Taxotere | DRUG | Docetaxel 100 mg/m2 every 3 weeks in the comparator arm |
| Sunitinib (Sutent) | DRUG | Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision |
Inclusion Criteria: * Breast cancer with evidence of unresectable locally recurrent, or metastatic disease * Her-2 negative tumors Exclusion Criteria: * Patients for whom docetaxel is contraindicated * Clinical presentation of inflammatory carcinoma with no other measurable disease
Taxotere is a small molecule oncology drug being studied for the treatment of breast neoplasms. It is currently in Phase 3 clinical development for this indication. Taxotere is being evaluated in combination with other therapies in patients with advanced or metastatic breast cancer.
Taxotere is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. Pfizer is conducting clinical trials to evaluate Taxotere in combination with other agents for the treatment of breast cancer.
Taxotere is currently in Phase 3 clinical development for breast cancer. It has completed two clinical trials, including a Phase 3 study with 594 participants. Taxotere is an investigational drug and has not been reported as approved for this indication.
Taxotere has been studied in two completed clinical trials for breast cancer. NCT00393939 was a Phase 3 study of sunitinib in combination with docetaxel versus docetaxel alone in 594 patients with advanced breast cancer. NCT00291577 was a Phase 1 study of SU011248 with docetaxel in 22 patients with metastatic breast cancer.
Taxotere is the brand name for docetaxel, a chemotherapy agent. In clinical trials, Taxotere is referred to as docetaxel, and it is being studied in combination with other drugs such as sunitinib for the treatment of advanced breast cancer.