At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
Paclitaxel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen
In Brief
A Phase 2 clinical trial evaluating Paclitaxel and Neulasta for Early Stage Breast Cancer. Completed, enrolled 127 participants across 4 sites.
Detailed Summary
This research study is testing the safety and feasibility of delivering the 4 cycles of 'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte Colony-stimulating Factor (G-CSF) support. The research study is for participants who have early stage breast cancer and have been recommended to receive a standard chemotherapy regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a "dose-dense" fashion to prevent recurrences.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Stage Breast Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionDec 2020
Study CompletionNov 2021
TodayJul 2026
First PostedMar 4, 2016
Enrollment StartApr 7, 2016
Primary CompletionDec 1, 2020
Study CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.3 years ago
Interventions
Paclitaxeldrug
Neulastadrug