A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer
Status and phase
Completed
Phase 2
Conditions
Breast Neoplasms
Treatments
Drug: Docetaxel
Drug: Paclitaxel
Drug: Gemcitabine
Details and patient eligibility
About
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
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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