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Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

Study acronym: PREFER
StatusActive, Not Recruiting
PhasePhase 3
SponsorBiocad
Started2023-01-30
View on ClinicalTrials.gov ↗

Amendment history

2025-07-17
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-01-22→confirmed 2025-06-06
Completion date2026-01-31→2026-02-20
Enrollment targetestimated 374→confirmed 398
Study sitesdetails revised at 3 of 3 sites
2023-09-18
Study Status, Study Design v1
Enrollment target336→374
2023-04-05
Original filing
Biocad
26 trials monitored
See all monitored trials
Breast Cancer
5,180 trials monitored
See 256 trials at risk
The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer. Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size \> 2 cm), with no estrogen (ER) and progesterone (PR) receptors will be randomized to one of two treatment groups (BCD-178 group or Perjeta group) in a 1:1 ratio.
Trial Details
NCT Number NCT05802225
Lead Sponsor Biocad
Conditions Breast Cancer
Enrollment 398 participants
Start Date 2023-01-30
Primary Completion 2025-06-06 (estimated)
Study Completion 2026-02-20 (estimated)
Updated on ClinicalTrials.gov 2025-07-20