A Three Arm Study of Adriamycin, Cyclophosphamide Plus Docetaxel vs Adriamycin Plus Cyclophosphamide Followed By Paclitaxel vs Adriamycin Plus Cyclophosphamide Followed By Paclitaxel and Gemcitabine in Adjuvant Breast Cancer
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: gemcitabine (Drug); paclitaxel (Drug); docetaxel (Drug); doxorubicin (Drug); cyclophosphamide (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern time (UTC/GMT-5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
Determine whether a regimen of dose-dense doxorubicin and cyclophosphamide followed by
dose-dense paclitaxel and gemcitabine will be superior to a regimen of docetaxel, doxorubicin
and cyclophosphamide as well as to a regimen of dose-dense doxorubicin and cyclophosphamide
followed by dose-dense paclitaxel alone.
Clinical Details
Official title: A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD-P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC-PG)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Disease free survival (DFS)
Secondary outcome: Overall survivalPharmacology toxicity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- A diagnosis of invasive cancer of the breast
- The interval between last surgery for breast cancer staging or treatment and
randomization must be no more than 84 days
- Must have had either a lumpectomy or mastectomy
- Must have no clinical or radiologic evidence of metastatic disease
- Must have good heart function by diagnostic test
Exclusion Criteria:
- HER 2 positive breast cancer
- The diagnosis of breast cancer in the opposite breast
- A prior history of breast cancer
- Prior therapy of anthracyclines or taxanes in the metastatic setting
- Pregnant
Locations and Contacts
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., Pittsburgh, Pennsylvania 15212, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: January 2004
Ending date: February 2011
Last updated: December 20, 2007
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