Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
Part of paid clinical trials in Lebanon, New Hampshire.
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Study ID
- NCT00014430
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- trastuzumab — BIOLOGICALTrastuzumab (INN; trade name Herceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers. The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell to inside the cell, and turn genes on and off. The HER proteins regulate cell growth, survival, adhesion, migration, and differentiation-functions that are amplified or weakened in cancer cells. In some cancers, notably some breast cancers, HER2 is over-expressed, and causes breast cells to reproduce uncontrollably.
- vinorelbine ditartrate — DRUGVinorelbine (trade name Navelbine) is an anti-mitotic chemotherapy drug that is given as a treatment for some types of cancer, including breast cancer and non-small cell lung cancer.
Study Details
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer.
Key Dates
- Start date
- Nov 30, 1999
- Status verified
- Nov 2002
- Primary completion
- Sep 30, 2002
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756-0002 | - |
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