CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 257 enrolled
Drug / intervention
pemetrexed +3 moredrug
Likely dose
Doxorubicin 60 mg/m² IV every 21 days × 4 cycles, then docetaxel 100 mg/m² IV every 21 days × 4 cycles (with either pemetrexed 500 mg/m² or cyclophosphamide 600 mg/m² in cycles 1-4)AI-extracted
Key inclusion· 3
  • ✓Histologically confirmed primary early breast cancer, tumor size ≥2 cm, Stages T2-T4/N0-2
  • ✓ECOG performance status 0-2
  • ✓Adequate organ function (bone marrow, hepatic, renal, cardiac)
Key exclusion· 5
  • ✕Prior anthracyclines as part of prior anticancer therapy
  • ✕Concurrent antitumor therapy
  • ✕Second primary malignancy
  • ✕Serious concomitant systemic disorder

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

Search/NCT00149214
NCT00149214Phase 2Completed
CompareCT.gov

A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer

Eli Lilly and Company·interventional·Posted Sep 8, 2005·Updated Mar 21, 2012

In Brief

A Phase 2 clinical trial evaluating pemetrexed, cyclophosphamide, and 2 other interventions for Breast Cancer. Completed, enrolled 257 participants across 11 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesGermany, Italy, Russia, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartSep 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.8 years ago

Interventions

pemetrexeddrug

500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

cyclophosphamidedrug

600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)

doxorubicindrug

60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

docetaxeldrug

100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)