drugset / Trial / NCT00930930

Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

NCT00930930 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-06
Primary completion
2013-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 5 mg Oral
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications