Phase 2
Completed N=68
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
Source: ClinicalTrials.gov NCT00191269 ↗Enrolled (actual)
68
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Tumor Response — 0; 1; 0; 4 participants
Summary
To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response |
0; 1; 0; 4; 1; 4 | — |
| SECONDARY Duration of Response |
10.07 | — |
| SECONDARY Time to Progressive Disease |
137; 92 | — |
| SECONDARY Survival at 1 Year |
4; 42 | — |
| SECONDARY Pharmacokinetics - Normalized Cmax |
29,036 | — |
| SECONDARY Pharmacokinetics - Normalized Area Under the Curve |
15,999 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically and/or cytologically confirmed breast cancer
- Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
- To have at least one measurable region
- PS: 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 carcinoma
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastasis with symptom
- To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Data sourced from ClinicalTrials.gov (NCT00191269). 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.