Phase 2
Completed N=60
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00316199 ↗Enrolled (actual)
60
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Best Overall Tumor Response — 2; 27; 20; 7 participants
Summary
The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Tumor Response |
2; 27; 20; 7; 0; 0 | — |
| SECONDARY Time to Treatment Failure |
4.5 | — |
| SECONDARY Progression-Free Survival |
7.6 | — |
| SECONDARY Duration of Response |
5.6 | — |
| SECONDARY Overall Survival Probability |
97; 87 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
- Unresectable, locally recurrent breast cancer or stage IV disease.
- Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
Exclusion Criteria
- Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Active infection or other serious condition.
- Pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT00316199). 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.