Clinical trial · Interventional
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer
NCT00191269CI-TRIAL-00003269completedPhase 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 GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Dose Level 1 - 1000 mg/m2
- interventionNames
- Drug: gemcitabine
- type
- EXPERIMENTAL
- label
- B
- description
- Dose Level 2 - 1250 mg/m2
- interventionNames
- Drug: gemcitabine
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.
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 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)
References
Publications (0)
Data not yet available
No reference posted for this study.