Clinical trial · Interventional
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
NCT00971945CI-TRIAL-00051971completedPhase 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 evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel
- interventionNames
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Number of Participants Experiencing Adverse Events
- timeFrame
- From first dose to end of follow-up period (up to approximately 33 months)
- description
- This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)
- measure
- Number of Participants Experiencing Laboratory Tests Abnormalities
- timeFrame
- From first dose to end of follow-up period (up to approximately 33 months)
- description
- This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed: * Enzyme investigations * Hematology investigations * Hepatobiliary investigations * Lipid investigations * Protein and chemistry analyses * Renal and urinary tract investigations * Water, electrolytes and mineral investigation. Laboratory test abnormalities were graded according to the NCI Common Toxicity Criteria version 2 (JCOG Version), resulting in a score from Grade 0 (Normal) to Grade 5 (Death due to toxicity). Only laboratory test abnormalities with a Grade 3 or higher are reported
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study
References
Publications (0)
Data not yet available
No reference posted for this study.