NCT00034489

Brief Summary

This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2002

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

April 29, 2002

Last Update Submit

July 18, 2006

Conditions

Keywords

metastatic breast cancercombination therapyAlimta

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis of breast cancer
  • measurable disease
  • received prior anthracycline and taxane
  • life expectancy \> 3 months
  • acceptable lab results

You may not qualify if:

  • \>3 prior regimens
  • prior treatment with protocol drugs
  • prior (pelvic) radiation
  • active CNS metastasis
  • inability to take oral vitamins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rochester, Minnesota, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PemetrexedGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 29, 2002

First Posted

April 30, 2002

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations