Phase 2
Completed N=62
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00334802 ↗Enrolled (actual)
62
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Tumor Response — 0; 0; 3; 25 participants — p=0.169
Summary
To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response |
0; 0; 3; 25; 1; 17 | 0.169 |
| SECONDARY Duration of Response |
4.70 | — |
| SECONDARY Time to Progressive Disease |
310.5; 194.0 | — |
| SECONDARY Number of Participants Alive at One Year (1-Year Survival) |
5; 45 | — |
| SECONDARY Pharmacokinetics - Maximum Plasma Concentration (Cmax) |
25800; 25400 | — |
| SECONDARY Pharmacokinetics - Area Under the Concentration Curve (AUC) |
16300; 14700 | — |
| SECONDARY Pharmacokinetics - Half Life (t½) |
0.282; 0.258 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically and/or cytologically confirmed breast cancer
- Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
- To have at least one measurable region
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion Criteria
- To have interstitial pneumonia or pulmonary fibrosis
- To have inflammatory breast cancer
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastases with symptoms
- To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
Data sourced from ClinicalTrials.gov (NCT00334802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.