NCT02698891

Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer

Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Low white cell blood counts increase the risk of infections; thus, in order to give each cycle of chemotherapy, white blood cell count must have recovered adequately in between cycles. Traditionally, this regimen has been given with the use of a medicine called Neulasta (Pegfilgrastim) to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time. The names of the study interventions involved in this study are: \-- Neulasta (Pegfilgrastim)

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel
DRUG	Neulasta

Timeline

• Start date: 2016-04-07
• Primary completion: 2020-12-01
• Completion: 2021-11-01
• First posted: 2016-03-04
• Last updated: 2022-05-06
• Results posted: 2022-05-06

Locations

4 sites across 1 country: United States