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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00442260
Brief Summary:
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) \[Phase I and II\]
Detailed Description:
Phase I Objectives
* To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
* Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.
Phase II Objectives
Primary Objective
* To determine the response rate of DOXIL and Abraxane in patients with MBC.
Secondary Objectives
* To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane.
* To assess the tolerability of this regimen in women with MBC and assess toxicity profile
Study:
NCT00442260
Study Brief:
Protocol Section:
NCT00442260