Phase 2
Completed N=6
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00971945 ↗Enrolled (actual)
6
Serious AEs
33.3%
Results posted
May 2021
Primary outcomePrimary: Number of Participants Experiencing Adverse Events — 6 Participants
Summary
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)"
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events |
6 | — |
| PRIMARY Number of Participants Experiencing Laboratory Tests Abnormalities |
1; 1 | — |
| SECONDARY Overall Response Rate (ORR) |
5 | — |
| SECONDARY Duration of Response (DOR) |
840 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00971945). 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.