CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
pemetrexeddrug
Likely dose
Pemetrexed 600 mg/m² intravenously every 14 daysAI-extracted
Key inclusion· 5
  • ✓Diagnosis of advanced or metastatic breast cancer
  • ✓No prior chemotherapy for advanced or metastatic breast cancer
  • ✓Advanced/metastatic diagnosis made at least 12 months after prior adjuvant chemotherapy
  • ✓Able to carry out light work activities
Key exclusion· 5
  • ✕Prior bone marrow or peripheral stem cell transplantation
  • ✕Prior chemotherapy for metastatic breast cancer
  • ✕Pregnancy or breast-feeding
  • ✕Active infection that would affect safety

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

Search/NCT00106002
NCT00106002Phase 2Completed
CompareCT.gov

A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

Eli Lilly and Company·interventional·Posted Mar 21, 2005·Updated Jun 1, 2009

In Brief

A Phase 2 clinical trial evaluating pemetrexed for Breast Cancer and 2 related conditions. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2005
Enrollment StartApr 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 21.3 years ago

Interventions

pemetrexeddrug

600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression