NCT01939418

Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer

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.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	RAD001	Afinitor 5mg qd. po.
DRUG	Gemcitabine	gemcitabine 800mg/m2 iv. D1 and D8 every 3 weeks
DRUG	Cisplatin	cisplatin 30mg/m2 iv. D1 and D8 every 3 weeks

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-07-30
• Completion: 2017-07-30
• First posted: 2013-09-11
• Last updated: 2017-10-03

Locations

1 site across 1 country: South Korea