Status:
COMPLETED
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Breast Cancer (MBC)
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
Eligibility Criteria
Inclusion
- Histologic diagnosis of metastatic breast cancer (MBC).
- Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
- Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
- Patients with measurable disease.
- Previous hormonal therapy for adjuvant setting or metastatic disease.
Exclusion
- Previous chemotherapy for MBC
- Previous chemotherapy with gemcitabine in any setting of disease
- Patient candidable to treatment with trastuzumab.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00236899
Start Date
September 1 2005
End Date
August 1 2010
Last Update
September 27 2011
Active Locations (34)
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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.
Avellino, Italy, 50019
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.
Bologna, Italy, 40100
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.
Brescia, Italy, 25124
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.
Cagliari, Italy, 09042