Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Phase 2 Completed 257 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

Timeline

Start: 2005-09
Primary completion: 2008-02
Completion: 2011-03

Publications

Results Schneeweiss A, Marme F, Ruiz A, Manikhas AG, Bottini A, Wolf M, Sinn HP, Mansouri K, Kennedy L, Bauknecht T. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Background	Docetaxel	Small molecule	100 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous

Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Summary

Timeline

Publications

Drugs

Indications