Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
NCT00136539 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2013-02-18
Summary
The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.
Conditions
Interventions
- DRUG
-
Given intravenously once weekly for 12 weeks prior to surgery.
- DRUG
-
Taxol
Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
- DRUG
-
Adriamycin
Given every three weeks for 12 weeks after surgery.
- DRUG
-
Cytoxan
Given every three weeks for 12 weeks after surgery.
Sponsors & Collaborators
- collaborator OTHER
-
Genentech, Inc.
collaborator INDUSTRY - collaborator INDUSTRY
-
Massachusetts General Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Harvard Vanguard Medical Associates
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER -
Harold J. Burstein, MD, PhD
lead OTHER
Principal Investigators
-
Harold Burstein, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-03-31
- Primary Completion
- 2006-11-30
- Completion
- 2012-03-31
Countries
- United States
Study Locations
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