RAD001 Plus Carboplatin in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01127763|
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: RAD001 Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of RAD001 Plus Carboplatin in Patients With Triple-Negative Metastatic Breast Cancer|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||March 2013|
Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
Other Name: Paraplatin
- Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months) [ Time Frame: up to 1 year ]Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
- Toxicity Profile-Hematological [ Time Frame: treatment period (up to 1 year) plus 30 days off treatment ]Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.
- Toxicity Profile-Non Hematological [ Time Frame: treatment period (up to 1 year) plus 30 days off treatment ]Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.
- Median Progression-free Survival Time [ Time Frame: up to 1 year ]Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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): NCT01127763
|United States, New York|
|NYU Clinical Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Amy Tiersten, MD||New York University School of Medicine|