Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xeloda · 1 trial · 1 indication
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
| Arm | Type | Description |
|---|---|---|
| Herceptin + Taxotere | EXPERIMENTAL | Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. |
| Herceptin + Taxotere + Xeloda | EXPERIMENTAL | Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. |
| Name | Type | Description |
|---|---|---|
| Xeloda | DRUG | Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle. |
| Taxotere | DRUG | Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm. |
| Herceptin | DRUG | Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward. |
Inclusion Criteria: * Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy * At least one measurable lesion according to RECIST * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Baseline left ventricular ejection ...
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Xeloda is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in a Phase 2 clinical trial in women with HER2-positive advanced and/or metastatic breast cancer. The drug is not yet approved and remains in clinical development.
Xeloda is a small molecule oncology drug. Its specific molecular target is not disclosed in the available information, so its mechanism of action is not described here. It is being investigated for its potential role in treating breast cancer.
Xeloda is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. Roche is conducting clinical research to evaluate the drug's safety and efficacy in breast cancer patients.
Xeloda is in Phase 2 clinical development. It is currently being studied in a Phase 2 trial for breast cancer, and the drug is not yet approved by regulatory authorities. It remains an investigational agent.
Xeloda is being studied in one completed Phase 2 clinical trial, NCT02748213, which enrolled 225 women with HER2-positive advanced and/or metastatic breast cancer. The trial was conducted across multiple countries including Australia, Brazil, Canada, and European nations.
No, Xeloda is not the same as Herceptin. Xeloda is a small molecule drug, while Herceptin (trastuzumab) is a different therapy. The clinical trial NCT02748213 studied Herceptin in combination with other treatments, and Xeloda is being developed separately by Roche.