Clinical trial · Interventional
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer
Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
NCT00316199CI-TRIAL-00002388completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: gemcitabine
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Best Overall Tumor Response
- timeFrame
- baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
- description
- Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Secondary outcomes (4)
- measure
- Time to Treatment Failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.