Phase II Study in Patients With Operable Breast Cancer
NCT00518583 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2010-01-15
Summary
The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
Conditions
Interventions
- DRUG
-
Pegylated Liposomal Doxorubicin (Doxil)
Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
Sponsors & Collaborators
-
Ortho Biotech Products, L.P.
collaborator INDUSTRY -
Aptium Oncology Research Network
lead NETWORK
Principal Investigators
-
John Macdonald, MD · CMO Aptium Oncology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2009-01-31
- Completion
- 2009-09-30
Countries
- United States
Study Locations
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