RecruitingPhase 2NCT06102824

Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial

Sponsor

Guangdong Provincial People's Hospital

Enrollment

252 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

HER2-negative Breast Cancer Advanced Breast Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is using patient-grown tumor "organoids" — tiny lab-grown models of a patient's own cancer grown from a biopsy — to predict which chemotherapy drugs will work best for each individual with advanced breast cancer. Researchers then choose treatment based on those lab results, testing a precision medicine approach for metastatic breast cancer. **You may be eligible if...** - You are 18 years or older (male or female) - You have confirmed advanced or metastatic breast cancer that is HER2-negative - Your cancer is either hormone receptor-positive or triple-negative - You have already received at least one prior treatment for your advanced cancer (or it recurred quickly after adjuvant chemotherapy) - Your cancer is measurable on imaging - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - Your tumor is HER2-positive - You have very poor performance status - Your liver, kidney, or blood counts cannot support further treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOrganoid-guided treatment

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).

DRUGTaxane

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

DRUGCapecitabine

1000-1250mg/m2, PO, bid, days1-14, q3w

DRUGGemcitabine

800-1200mg/m2, IV, days 1, 8, q3w

DRUGVinorelbine

20-35mg/m2, IV, days 1 and 8, q3w

DRUGEribulin

1.4mg/m2, IV, days 1 and 8, q3w

DRUGAnthracycline

Liposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w

DRUGCarboplatin

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

DRUGUtidelone

30mg/m2, IV, once per day on days 1-5, q3w

DRUGTrastuzumab deruxtecan

5.4mg/kg, IV, q3w

DRUGSacituzumab govitecan

10mg/kg, IV, days 1 and 8, q3w