Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02028494
Brief Summary:
The purpose of this study is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer.
Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug and previous studies done al Memorial Sloan Kettering Cancer Center support the tolerability of this scheme.
This definitive, randomized trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer is necessary and we hypothesize it will be superior in terms of efficacy.
Dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. This trial is a proof of principle trial of the highest priority.
Study:
NCT02028494
Study Brief:
Protocol Section:
NCT02028494