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Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer

Study acronym: BREASTIMMU02
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v17
  2. Primary completion date: Jan 2025 to Jan 2027
    • Study completion date: Sep 2025 to Sep 2027
    • Site contacts updated at 1 of 9 sites
    v16
  3. Primary completion date: Apr 2024 to Jan 2025
    • Study completion date: Apr 2024 to Sep 2025
    v15
  4. Site contacts updated at 1 of 9 sitesv14
  5. Primary and study completion dates: Apr 2022 to Apr 2024
    • Study sites revised (9)
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Site contacts updated at 1 of 9 sitesv12
  2. Primary and study completion dates: Nov 2021 to Apr 2022
    • Eligibility criteria expanded, about 20 words
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Study sites: 7 to 9
    • Eligibility criteria expanded, about 3 words
    v9
  5. Re-verified, no change to tracked fieldsv8
  6. Study sites: 5 to 7v7
  7. Site details revised at 1 of 5 sitesv6
  8. Site details revised at 1 of 5 sitesv5
  9. Study sites: 1 to 5v4
  10. Primary completion date: Jul 2018 to Nov 2021
    • Study completion date: Oct 2021 to Nov 2021
    • Start date changed from estimate of Jul 2018 to Aug 6, 2018
    v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for immunotherapy with mAb possessing ADCC/ADCP properties as trastuzumab. Combined treatment of pegfilgrastim and trastuzumab should translate into an increased rate of pathological clinical response. Therefore the investigators' proposal is to evaluate the clinical and biological impact of pegfilgrastim in combination with trastuzumab + paclitaxel in HER2-positive early stage breast cancer patients. Breastimmune02 is a multicenter, randomized, open-label, Phase II trial. Operable HER2+ breast cancer patients previously treated with 4 cycles of standard adriamycine/cyclophosphamide (AC) chemotherapy will be randomized (1:1) to receive in the neoadjuvant setting:Arm A: weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) + pegfilgrastim (Q3W) versus Arm B: weekly paclitaxel + trastuzumab (Q3W).Stratification criteria will be: cN0 versus cN1.
Trial Details
NCT Number NCT03571633
Lead Sponsor Centre Leon Berard
Collaborators: Amgen
Conditions
(from sponsor)		 HER2-positive Breast Cancer, Operable Breast Cancer
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov