Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT02467868
Brief Summary:
This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.
Detailed Description:
After successful screening, eligible patients will be randomly allocated to one of the two study arms, either receiving MYL-1401H or Neulasta.
Randomization is 2:1 to MYL-1401H or Neulasta, respectively.
Subjects will receive first of six cycles of background therapy (Docetaxel, Doxorubicin, Cyclophosphamide \[TAC\]) on day 1. Treatment with study drug (either MYL-1401H or Neulasta) is scheduled on Day 2 of each cycle, at least 24 hours after chemotherapy administration.
Duration of each cycle is 3 weeks.
Follow-up visit is scheduled 24 weeks after the first administration of study drug.
Study:
NCT02467868
Study Brief:
Protocol Section:
NCT02467868