Status:
TERMINATED
Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Amgen
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Trastuzumab or Herceptin is an antibody directed against Her-2. Her-2 is a growth factor receptor which is present on the tumors of 25% of patients with breast cancer. The addition of trastuzumab to c...
Detailed Description
This is a randomized phase II study comparing trastuzumab with G-CSF against trastuzumab with placebo during the first two weeks of therapy. Twenty five patients with metastatic breast cancer will be...
Eligibility Criteria
Inclusion
- All patients must have pathological confirmation of carcinoma of the breast.
- Patients must have metastatic breast cancer by documented clinical or radiological assessment.
- Immunohistochemical analysis of HER-2/neu expression on paraffin-embedded specimens will be performed. HER-2/neu overexpression will be qualitatively scored as 0, 1+, 2+, or 3+, with 3+ indicating the strongest positivity. Fluorescence In Situ Hybridization (FISH) analyses will also be performed on these patients. Patients with 2+ to 3+ overexpression of HER-2/neu (membranous staining) are eligible, regardless of the results of the FISH analysis.
- Age ≥18 years.
- Karnofsky performance status ≥ 60%.
- Adequate hepatic, renal, and hematologic function.
- Prior treatment with trastuzumab will be allowed.
- All patients must have adequate cardiac function (defined as left ventricular ejection fraction ≥ 45%) documented by echocardiogram or MUGA scan.
- Premenopausal women will be required to have a negative urine or serum pregnancy test and to use an effective form of contraception.
- Patients with a history of brain metastases are permitted as long as it has been at least 30 days since definitive treatment, they are clinically stable and a magnetic resonance imaging scan of the brain demonstrates control of the lesion(s).
- All patients must give written informed consent indicating they are aware of the investigational nature of this treatment, as well as the risks and benefits of this protocol.
Exclusion
- No treatment with chemotherapy or trastuzumab will be allowed within four weeks of study entry.
- Prior therapy with vinorelbine.
- Known history of hypersensitivity to trastuzumab, Chinese hamster ovary (CHO) cell proteins, or any component of these products.
- History of current unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months.
- Pregnant women are excluded.
- History of a known hypersensitivity to E. coli-derived proteins, filgrastim, or any component of the product.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00169104
Start Date
July 1 2002
End Date
March 1 2009
Last Update
July 20 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.