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NCT02436993

Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

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Record History

All 12 versions: 11 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 12, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints revised (4)
    • Primary endpoint revised
    • Site details revised
  2. Primary completion date changed from estimate of Jun 2025 to Nov 2023
    • Study completion date: Jun 2025 to Dec 2036
    v11
  3. Primary and study completion dates: Jun 2024 to Jun 2025v10
  4. Primary and study completion dates pushed to Jun 2024v9
  5. Primary completion date: Dec 2021 to Jun 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2022 to Dec 2023
    • Site details revised
    v8
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Aug 2040 to Dec 2021
    • Eligibility criteria expanded, about 98 words
    • Study completion date: Aug 2040 to Dec 2022
    v7
  2. Eligibility criteria shortened, about 82 words
    • Study description shortened, about 156 words
    v6
  3. Primary and study completion dates pushed to Aug 2040v5
  4. Study title shortened, about 7 wordsv3
  5. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

2-year Progression Free Survival in Patients Treated With Weekly Carboplatin and Paclitaxel Combined With Either Trastuzumab and Pertuzumab for HER2-positive Patients or Bevacizumab for HER2-negative Patients in the Neoadjuvant Setting
Timeframe: 2 years

Secondary (4)

Clinical Complete Response Rates
Pathologic Complete Response Rates
Number of Toxicities in Carboplatin+Paclitaxel+Bevacizumab (HER2) Arm
Number of Toxicities in Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

Arms and interventions

Carboplatin+Paclitaxel+Bevacizumab (HER2-)Experimental

Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Bevacizumab every other week, 5 doses

Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)Experimental

Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Trastuzumab weekly 12 doses Pertuzumab every 3 weeks, 4 doses

Drugs: Carboplatin, Paclitaxel, Bevacizumab, Trastuzumab, Pertuzumab

Sites

1 site in 1 country

  • UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United States