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Also known as capecitabine
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 studied for breast cancer, specifically in a Phase 2 trial of women with HER2-positive advanced and/or metastatic breast cancer. The trial enrolled 225 female participants aged 18 years and older across multiple countries including Australia, Brazil, Canada, and several European nations.
Xeloda is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical trial evaluating Xeloda in breast cancer.
Xeloda is in Phase 2 clinical development for breast cancer. The single listed trial, NCT02748213, is a completed Phase 2 study. Xeloda is investigational in this setting and has not been approved for this indication based on the available trial data.
Xeloda has been evaluated in one completed Phase 2 trial, NCT02748213, titled "A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer." The trial enrolled 225 female participants and was controlled and randomized.
Yes, the Xeloda Phase 2 trial NCT02748213 was biomarker-selected, enrolling women with HER2-positive advanced and/or metastatic breast cancer. The study was randomized and controlled, with 225 participants across sites in Australia, Brazil, Canada, Costa Rica, Finland, France, Greece, Guatemala, Italy, Mexico, Panama, Poland, Spain, Sweden, and the United Kingdom.