Conditions: Metastatic Breast Cancer
Keywords: breast cancer advanced breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

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

Arms:
arm 1: Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.

Interventions: intervention 1: DOXIL intervention 2: Abraxane
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: