Phase II Study of The Efficacy And Safety of Chloroquine (C) in CombinAtion With Taxane or Taxane-like (T) Chemo Agents in The Treatment of Patients With Advanced or Metastatic Breast Cancer Who Have Failed Anthracycline Chemo Base Therapy.
The purpose of this study is to determine the anti-tumor activity of the combination of
Chloroquine combined with a Taxane or Taxane-like chemo agents(Paclitaxel, Docetaxel,
The laboratories have developed robust preclinical models utilizing both in vitro systems
such as the mammosphere (MS) culture and in vivo systems such as human breast cancer
xenografts allowing the investigators to identify agents which selectively target TICs, as
single agents or in combination. These models are critical since tumor initiating cells
(TICs) comprise only a small percentage of the tumor bulk, so that clinical tumor regression
may not be observed with inhibitors that selectively target TIC self-renewal alone.
Nonetheless, these agents in combination with conventional therapy may effectively kill both
actively cycling or fully differentiated cells and the TIC subpopulation, leading to long
term remission and eradication of cancer cells.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
To determine the anti-tumor activity of the combination of Chloroquine + Taxane or Taxane-like chemo agents (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) (C/T) measured by overall Response Rate (ORR).
Jenny C Chang, MD
The Methodist Hospital System
United States: Institutional Review Board
|The Methodist Hospital Cancer Center||Houston, Texas 77030|