Status:
COMPLETED
A Study of Pemetrexed Plus Doxorubicin Given to Patients With Advanced Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin have been combined with other...
Eligibility Criteria
Inclusion
- Diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment.
- Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy.
- At least one measurable lesion.
- No chemotherapy within 4 weeks prior to enrollment.
- Signed informed consent from the patient.
Exclusion
- Prior chemotherapy for metastatic breast cancer.
- Prior treatment with any anthracyclines or anthracenedione-containing regimen.
- Treatment within the last 30 days with any drug that has not received regulatory approval.
- Pregnancy and/or breast feeding.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00102219
Start Date
October 1 2004
End Date
October 1 2007
Last Update
November 30 2007
Active Locations (12)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Belo Horizonte, BH, Brazil
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
São Paulo, São Paulo, Brazil
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Rio de Janeiro, Brazil
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Athens, Greece