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
18 Years
70 Years
Female
Breast Cancer
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With a Pathological Complete Response
Outcome Description:
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
Outcome Time Frame:
surgery after eight 21-day cycles of chemotherapy
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Chair
Investigator Affiliation:
Eli Lilly and Company
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
7113
NCT ID:
NCT00149214
Start Date:
September 2005
Completion Date:
March 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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