CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
cisplatin +4 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/NCT00930930
NCT00930930Phase 2Completed

A Phase II Neo-Adjuvant Study of Cisplatin, Paclitaxel With or Without RAD001 in Patients With Triple-negative Locally Advanced Breast Cancer.

Vanderbilt-Ingram Cancer Center·interventional·Posted Jul 2, 2009·Updated May 7, 2015

In Brief

A Phase 2 clinical trial evaluating cisplatin, everolimus, and 3 other interventions for Breast Cancer. Completed, enrolled 145 participants across 8 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 chemotherapy together with everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether cisplatin and paclitaxel are more effective when given together with or without everolimus in treating patients with breast cancer. PURPOSE: This randomized phase II trial is studying how well cisplatin and paclitaxel work when given together with or without everolimus in treating patients with stage II or stage III breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17 years ago

Interventions

cisplatindrug

Given IV

everolimusdrug

Given orally

paclitaxeldrug

Given IV

placeboother

Given orally

Venous blood drawprocedure

Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment