Clinical Trial

Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer

Study acronym: BOLD-1
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated February 11, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This randomized clinical trial compares two systemic treatments for HER2-positive breast cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment) or after breast surgery (as adjuvant treatment). In the investigational group (Group A) the study participants will receive a combination of two drugs directed at HER2 (two anti-HER2 antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients allocated to the comparator group (Group B) will be treated with chemotherapy plus one anti-HER2 treatment (trastuzumab) for one year.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2015-12-08; most recent amendment 2025-02-08.
Status change: Recruiting → Active, Not Recruiting 2021-12-31
Trial Details
NCT Number NCT02625441
Lead Sponsor Helsinki University Central Hospital
Conditions Breast Cancer
Enrollment 516 participants
Start Date 2015-12
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-11