Clinical trial · Interventional
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline
NCT00334802CI-TRIAL-00003268completedPhase 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)
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
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
- Tumor Response
- timeFrame
- baseline to measured progressive disease
- 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. Responders are patients with complete response or partial response.
Secondary outcomes (6)
- measure
- Duration of Response
- timeFrame
- time of response to progressive disease
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.