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Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Study acronym: ORIENTA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Start date changed from estimate of Sep 25, 2024 to Oct 1, 2024
    • Collaborators revised (3)
    v6
  2. Start date: Jan 20, 2024 to Sep 25, 2024
    • Collaborators revised (3)
    v5
  3. Interventions: Anthracycline (Drug), Capecitabine (Drug), Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Ixabepilone (Drug), Organoid-guided… to Anthracycline (Drug), Capecitabine (Drug), Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Organoid-guided treatment (Drug)…v4
  4. Interventions: Capecitabine (Drug), Eribulin (Drug), Gemcitabine (Drug), Organoid-guided treatment (Drug), Taxane (Drug), Vinorelbine (Drug) to Anthracycline (Drug), Capecitabine (Drug), Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Ixabepilone (Drug), Organoid-guided…v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 1, 2023 to Jan 20, 2024
    • Site details revised
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.
Trial Details
NCT Number NCT06102824
Lead Sponsor Guangdong Provincial People's Hospital
Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Shantou Central Hospital
Conditions
(from sponsor)		 HER2-negative Breast Cancer, Advanced Breast Cancer
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov