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

Study acronym: BOLD-1
StatusActive, Not Recruiting
PhasePhase 3
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jul 31, 2025 to Jun 1, 2025
    • Study description revised
    • Study site revised
    v10
  2. Primary completion date: Dec 31, 2021 to Jul 31, 2025
    • Study completion date: Jun 2025 to Jul 31, 2025
    v9
  3. Enrollment target: estimated 1366 to confirmed 516v8
  4. Primary completion date changed from estimate of Dec 2021 to Dec 31, 2021v7
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2022 to Dec 2021
    • Study completion date: Jun 2023 to Jun 2025
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. 2 versions Re-verified since Feb 12, 2020, no change to tracked fieldsv4-v5
  2. Secondary endpoints: 5 to 4v3
  3. Secondary endpoints: details revised at 5 of 5 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02625441
Lead Sponsor Helsinki University Central Hospital
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 516 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov