Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT06102824
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer
  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Organoid-guided treatment — DRUG
    The drugs predicted to be the most sensitive through organoid drug sensitivity screening. The drugs selected for sensitivity screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
  • Taxane — DRUG
    Albumin-bound paclitaxel 260mg/m2, IV, q3w, or 100-125mg/m2, IV, days 1, 8, and 15, q4w OR Liposomal paclitaxel 175mg/m2, IV, q3w
  • Capecitabine — DRUG
    1000-1250mg/m2, PO, bid, days1-14, q3w
  • Gemcitabine — DRUG
    800-1200mg/m2, IV, days 1, 8, q3w
  • Vinorelbine — DRUG
    20-35mg/m2, IV, days 1 and 8, q3w
  • Eribulin — DRUG
    1.4mg/m2, IV, days 1 and 8, q3w
  • Anthracycline — DRUG
    Liposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w
  • Carboplatin — DRUG
    Carboplatin AUC 6, IV, q3w or q4w OR Carboplatin AUC 2+Gemcitabine 1000mg/m2, IV, days 1 and 8, q3w OR Carboplatin AUC 2+Albumin-bound paclitaxel 125mg/m2, IV, days 1 and 8, q3w
  • Utidelone — DRUG
    30mg/m2, IV, once per day on days 1-5, q3w
  • Trastuzumab deruxtecan — DRUG
    5.4mg/kg, IV, q3w
  • Sacituzumab govitecan — DRUG
    10mg/kg, IV, days 1 and 8, q3w

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Organoid-guided treatment
    Subjects randomized to the organoid-guided treatment (OGT) group will be treated with the drugs predicted to be the most sensitive through PDO drug sensitivity screening. Drugs that the subjects have progressed on before randomization will not be screened. The drugs selected for organoid screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
  • Active Comparator: Treatment of physician's choice
    Subjects randomized to the treatment of physician's choice (TPC) group will receive physician-chosen therapy from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).

Primary Outcome Measure

Progression-free survival [ Time Frame: Through study completion, with an expected average of 1 year ]

Central Contacts

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