Breast Cancer, Breast Neoplasms, Cancer of the Breast
Conditions
Brief summary
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.
Interventions
DRUGGemcitabine
DRUGTrastuzumab
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease * Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2. Tumors that are 3+ by IHC but negative by FISH assay are ineligible * Patients must have measurable disease * Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer. * Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months.
Exclusion criteria
* Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval * Patients with known leptomeningeal carcinomatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Overall response rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression,Time to treatment failure, Overall survival, Toxicity of the combination | — |
Countries
United States
Outcome results
None listed