Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01088893|
Recruitment Status : Unknown
Verified May 2012 by Organisation for Oncology and Translational Research.
Recruitment status was: Recruiting
First Posted : March 17, 2010
Last Update Posted : May 24, 2012
This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy.
Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients will be monitored for efficacy and safety.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of mTOR Inhibition by RAD001 (Everolimus) in Invasive Breast Cancer Patients After Pre-operative Use of Anthracycline and/or Taxane-based Chemotherapy|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
|No Intervention: observation|
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
- measure change of biomarkers in pre- and post- surgery samples [ Time Frame: baseline and 1 month ]
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): NCT01088893
|Contact: Louis Chow, MD||(852)28610286|
|Unimed Medical Institute||Recruiting|
|Hong Kong, China|
|Contact: Louis Chow, MD (852)28610286|