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A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Liposomal Doxorubicin * Docetaxel For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Tennessee Oncology
Nashville, Tennessee, United States
Start Date
February 1, 2001
Primary Completion Date
December 1, 2008
Completion Date
November 1, 2009
Last Updated
July 31, 2013
102
ACTUAL participants
Liposomal Doxorubicin
DRUG
Docetaxel
DRUG
Lead Sponsor
SCRI Development Innovations, LLC
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
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