Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT) (CAT)
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|ClinicalTrials.gov Identifier: NCT01446016|
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : April 16, 2019
The major purpose of this research study is to better understand how therapy works on different patients. This study is being offered to patients with a diagnosis of advanced or metastatic breast cancer who have failed anthracycline based therapy.
The investigators want to see the response of breast cancer cell when treated with Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel) or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Breast Cancer||Drug: Taxane Drug: Docetaxel Drug: Abraxane Drug: Ixabepilone||Phase 2|
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, Abraxane, Ixabepilone).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 1, 2019|
Active Comparator: Taxane
Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.
Other Name: Paclitaxel
Active Comparator: Taxane-Like
Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone)
Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks
Other Name: Taxne-like
Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.
Other Name: Taxane-like
Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Other Name: Taxane-like
- Overall Response Rate (ORR) [ Time Frame: One Year ]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).
- Safety and Tolerability [ Time Frame: One Year ]To assess the safety and tolerability of the combination of Chloroquine and Taxane or Taxane-Like chemo.
- Tumor Control Rate [ Time Frame: One Year ]To assess the response rate and tumor control rate (TCR) of patients receiving Chloroquine + Taxane or Taxane-like.
- Time to Progression [ Time Frame: One Year ]To assess the Time to Progression (TTP) of patients receiving Chloroquine + Taxane or Taxane-like chemo.
- Duration of Response [ Time Frame: Three Years ]To assess the duration of response (DOR) of patients receiving Chloroquine + Taxane or Taxane-like chemo agents.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446016
|United States, Texas|
|Houston Methodist Hospital Cancer Center|
|Houston, Texas, United States, 77030|
|Houston Methodist Hospital Willowbrook|
|Houston, Texas, United States, 77070|
|Houston Methodist Hospital Sugar Land|
|Sugar Land, Texas, United States, 77479|
|Principal Investigator:||Jenny C Chang, MD||The Methodist Hospital System|