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Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00097383
Enrollment
Unknown
Registered
2004-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.

Interventions

DRUGALIMTA plus Epirubicin

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment. * Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy. * Patients must have at least one measurable lesion in an area not previously irradiated. * No chemotherapy at least 4 weeks prior to study enrollment. * Signed informed consent from patient.

Exclusion criteria

* Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious systemic disorders, including active infection. * Significant cardiovascular disease. * Pregnancy or breast feeding. * Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

Countries

Argentina, Belgium, Brazil, Mexico, Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026