Status:
COMPLETED
Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00097383
Last Update
July 19 2006
Active Locations (25)
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1
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
La Plata, Buenos Aires, Argentina
2
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Rosario, Santa Fe Province, Argentina
3
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Buenos Aires, Argentina
4
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Ciudad de Buenos Aires, Argentina