Organoid-based Functional Precision Therapy for Advanced Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
HER2-negative Breast CancerAdvanced 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

Trial Locations (1)

510080

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

All Listed Sponsors
collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Sun Yat-sen University

OTHER

collaborator

Shantou Central Hospital

OTHER

lead

Guangdong Provincial People's Hospital

OTHER