CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
cisplatin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01031446
NCT01031446Phase 2Completed

A Phase Ib/II Study of Cisplatin, Paclitaxel, and RAD001 in Patients With Metastatic Breast Cancer

Vanderbilt-Ingram Cancer Center·interventional·Posted Dec 14, 2009·Updated Aug 31, 2018

In Brief

A Phase 2 clinical trial evaluating cisplatin, everolimus, and 2 other interventions for Breast Cancer. Completed, enrolled 55 participants across 4 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving cisplatin and paclitaxel together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin and paclitaxel together with everolimus and to see how well it works in treating patients with metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2011
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.6 years ago

Interventions

cisplatindrug

Given through a vein in the arm 1 time a week for 3 weeks, then a one week break and then begin the process again.

everolimusdrug

Taken daily by mouth.

paclitaxeldrug

Given through a vein in the arm 1 time a week for 3 weeks, then a one week break and then begin the process again.

laboratory biomarker analysisother

Blood collection