Breast Neoplasms
Conditions
Brief summary
The combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. Several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. Overall responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever
Interventions
DRUGGemcitabine
DRUGPaclitaxel
DRUGDocetaxel
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic breast cancer * Disease that can be measured by the physician or radiologic test. * May have had one chemotherapy treatment for advanced or metastatic disease. * Patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment. * Patients may have received prior hormone therapy or immunotherapy.
Exclusion criteria
* Patients with only non-measurable disease * Cancer that has spread to the brain * A patient who received a taxane with metastatic disease. * Pregnancy * Patients who received prior gemcitabine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate the response rate of two regimens separately. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimate the following activities of two regimens separately:Progression-free survival;Time to progressive disease;duration of response;Overall survival, changes in performance status | — |
| Nature of toxicities experienced on each arm of the study | — |
Countries
United States
Outcome results
None listed