Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Overview[ - collapse ][ - ]
Purpose | An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0). |
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Condition | Breast Cancer |
Intervention | Drug: pemetrexed Drug: cyclophosphamide Drug: doxorubicin Drug: docetaxel |
Phase | Phase 2 |
Sponsor | Eli Lilly and Company |
Responsible Party | Eli Lilly and Company |
ClinicalTrials.gov Identifier | NCT00149214 |
First Received | September 2, 2005 |
Last Updated | March 15, 2012 |
Last verified | March 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | September 2, 2005 |
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Last Updated Date | March 15, 2012 |
Start Date | September 2005 |
Estimated Primary Completion Date | March 2011 |
Current Primary Outcome Measures | Number of Participants With a Pathological Complete Response [Time Frame: surgery after eight 21-day cycles of chemotherapy] [Designated as safety issue: No]pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens |
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Official Title | A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer |
Brief Summary | An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: pemetrexed 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) Other Names: LY231514, AlimtaDrug: cyclophosphamide 600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4) Drug: doxorubicin 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) Drug: docetaxel 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 257 |
Estimated Completion Date | March 2011 |
Estimated Primary Completion Date | February 2008 |
Eligibility Criteria | Inclusion Criteria: - Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2. - Performance status 0-2 Eastern Cooperative Oncology Group (ECOG). - Adequate organ function (bone marrow, hepatic, renal, cardiac). Exclusion Criteria: - Prior anthracyclines as part of prior anticancer therapy. - Concurrent antitumor therapy. - Second primary malignancy. - Serious concomitant systemic disorder. - Pre-existing sensorial or motor neuropathy - Grade 1. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Germany, Italy, Russian Federation, Spain |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00149214 |
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Other Study ID Numbers | 7113 |
Has Data Monitoring Committee | No |
Information Provided By | Eli Lilly and Company |
Study Sponsor | Eli Lilly and Company |
Collaborators | Not Provided |
Investigators | Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company |
Verification Date | March 2012 |
Locations[ + expand ][ + ]
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, 76532 |
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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. | Berlin, Germany, 10967 |
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. | Hamburg, Germany, 20357 |
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, D-69115 |
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, 26100 |
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, 20089 |
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, Russian Federation, 129128 |
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. | Saint Petersburg, Russian Federation, 197022 |
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. | Jaen, Spain, 23007 |
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, 08208 |
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, 46010 |