Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
NCT ID: NCT00149214
Last Updated: 2012-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
257 participants
INTERVENTIONAL
2005-09-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
pemetrexed
500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)
doxorubicin
60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)
docetaxel
100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
doxorubicin
60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)
docetaxel
100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Interventions
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pemetrexed
500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)
cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
doxorubicin
60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)
docetaxel
100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
* Adequate organ function (bone marrow, hepatic, renal, cardiac).
Exclusion Criteria
* Concurrent antitumor therapy.
* Second primary malignancy.
* Serious concomitant systemic disorder.
* Pre-existing sensorial or motor neuropathy
* Grade 1.
18 Years
70 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_CHAIR
Eli Lilly and Company
Locations
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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.
Baden-Baden, , Germany
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.
Berlin, , Germany
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Hamburg, , Germany
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.
Heidelberg, , Germany
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.
Cremona, , Italy
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.
Rozzano, , Italy
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.
Moscow, , Russia
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Saint Petersburg, , Russia
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.
Jaén, , Spain
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.
Sabadell, , Spain
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.
Valencia, , Spain
Countries
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References
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Schneeweiss A, Marme F, Ruiz A, Manikhas AG, Bottini A, Wolf M, Sinn HP, Mansouri K, Kennedy L, Bauknecht T. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.
Other Identifiers
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H3E-MC-S080
Identifier Type: OTHER
Identifier Source: secondary_id
7113
Identifier Type: -
Identifier Source: org_study_id
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