ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC

StatusUnknown
PhasePhase 2
Started

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2023); last known: Active, Not Recruiting
  2. Primary completion date changed from estimate of Apr 1, 2021 to Sep 30, 2023v3 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 180 to 156
    • Study completion date: Jan 1, 2022 to Sep 30, 2026
    • Interventions: Cyclophosphamide (Drug), Docetaxel (Drug), Doxorubicin liposome (Drug), Epirubicin (Drug), Trastuzumab (Drug) to Cyclophosphamide (Drug), Docetaxel (Drug), Doxorubicin liposome (Drug), Epirubicin (Drug), Paclitaxel (Drug), Paclitaxel-albumin (Drug)…
    • Study description expanded, about 60 words
    • Site details revised
    • Study title revised
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2019 to Jan 10, 2019
    v2
  4. Study First Submitted
  • 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.
Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy. We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients.
Trial Details
NCT Number NCT04172259
Lead Sponsor Sun Yat-sen University
Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions
(from sponsor)		 Breast Cancer, Neoadjuvant Chemotherapy
Related terms Breast Neoplasms
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov