Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01939418|
Recruitment Status : Terminated (slow recruitment)
First Posted : September 11, 2013
Last Update Posted : October 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: RAD001 Drug: Gemcitabine Drug: Cisplatin||Phase 1 Phase 2|
PIK3CA active mutations are the most frequent genetic event in breast cancer, including in TNBC which presents activated PI3K/AKT signaling due to PIK3CA mutation or PTEN deficiency. TNBC cell lines having activated PI3K/AKT signaling showed a high sensitivity to PI3K/mTOR inhibitors. RAD001 is a potent mTOR complex 1 inhibitor and showed to enhance cisplatin or gemcitabine induced apoptosis by inhibiting p53 induced p21 expression.
This study consists of two parts. In a phase Ib part, investigators will explore the recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with metastatic TNBC. After completing the phase Ib part, investigators will review the data and discuss with Novartis before the start of a phase II part. In the phase II part, investigators will compare the efficacy of the gemcitabine and cisplatin with or without RAD001 in patients with metastatic TNBC.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Trial of Gemcitabine and Cisplatin With RAD001 in Patients With Metastatic Triple Negative Breast Cancer Proceeding to an Open Label Randomized Phase II Trial Comparing Gemcitabine/Cisplatin With or Without RAD001.|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||July 30, 2016|
|Actual Study Completion Date :||July 30, 2017|
gemcitabine 800mg/m2, D1 and D8 iv. every 3 weeks. cisplatin 30mg/m2, D1 and D8 iv. every 3 weeks. RAD001 5mg QD. po.
Afinitor 5mg qd. po.
gemcitabine 800mg/m2 iv. D1 and D8 every 3 weeks
cisplatin 30mg/m2 iv. D1 and D8 every 3 weeks
- The recommended dose of the combination of gemcitabine, cisplatin and RAD001 (everolimus) in patients with metastatic triple-negative breast cancer [ Time Frame: up to 1 year ]phase IB part
- Efficacy of gemcitabine and cisplatin with or without RAD001 in patients with metastatic triple-negative breast cancer by evaluating progression free survival (PFS) [ Time Frame: up to 5 years ]phase II part
- The maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of gemcitabine/cisplatin/RAD001 [ Time Frame: up to 1 year ]phase Ib part
- number of patients with adverse events as a measure of safety and tolerability [ Time Frame: up to 5 years ]phase Ib and phase II
- objective response rate [ Time Frame: up to 1 year ]phase Ib and phase II
- Overall survival (OS) [ Time Frame: up to 5 years ]phase Ib and phase II
- check biomarkers associated with the response of RAD001: angiogenesis, metabolism, immune cells profiles [ Time Frame: up to 5 years ]phaseIb and phaseII
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): NCT01939418
|Korea, Republic of|
|National cancer center|
|Goyangsi, Gyeonggido, Korea, Republic of, 410-769|
|Principal Investigator:||In Hae Park, Doctor||National Cancer Center, Korea|