Organoid-based Functional Precision Therapy for 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.

Conditions

• HER2-negative Breast Cancer
• Advanced Breast Cancer

Interventions

DRUG

Organoid-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).

DRUG

Taxane

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

DRUG

Capecitabine

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

DRUG

Gemcitabine

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

DRUG

Vinorelbine

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

DRUG

Eribulin

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

DRUG

Anthracycline

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

DRUG

Carboplatin

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

DRUG

Utidelone

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

DRUG

Trastuzumab deruxtecan

5.4mg/kg, IV, q3w

DRUG

Sacituzumab govitecan

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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Shantou Central Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2027-06-30

Completion

2028-06-30

Countries

• China

Study Locations