NCT06102824: ORIENTA

Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Recruiting now Phase 2 Last updated 25 November 2024

What this trial tests

Phase 2 trial testing Organoid-guided treatment in HER2-negative Breast Cancer in 252 participants. Currently enrolling.

Timeline

1 October 2024

Primary endpoint
30 June 2027

30 June 2028

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	252
Start date	1 October 2024
Primary completion	30 June 2027
Estimated completion	30 June 2028
Sites	1 location across China

Drugs / interventions tested

• Organoid-guided treatment — full drug profile →
• Taxane
• Capecitabine (capecitabine) — full drug profile →
• Gemcitabine
• Vinorelbine
• Eribulin (ERIBULIN) — full drug profile →
• Anthracycline
• Carboplatin (Carboplatin) — full drug profile →
• Utidelone
• Trastuzumab deruxtecan — full drug profile →
• Sacituzumab govitecan

Conditions studied

• HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →
• Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

Guangdong Provincial People's Hospital

Who can join

Adults 18 to 80, any sex, with HER2-negative Breast Cancer or Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine.
   Yao Q, Cheng S, Pan Q, Yu J, et al · · 2024 · cited 40× · PMID 39309690 · DOI 10.1002/mco2.735
2. Tumour organoids and assembloids: Patient-derived cancer avatars for immunotherapy.
   Mei J, Liu X, Tian HX, Chen Y, et al · · 2024 · cited 25× · PMID 38664597 · DOI 10.1002/ctm2.1656
3. Organoids in Cancer Research and Regenerative Medicine: Current Status, Challenges, and Future Prospects.
   Li R, Wu Y, Zheng Z, Zhou F, et al · · 2026 · cited 1× · PMID 41503026 · DOI 10.1002/mco2.70575
4. Single-cell sequencing and organoids: applications in organ development and disease.
   Li T, Yin J, Hao Y, Gao W, et al · · 2025 · cited 1× · PMID 41359105 · DOI 10.1186/s43556-025-00364-6
5. Ex Vivo Intestinal Organoid Models: Current State-of-the-Art and Challenges in Disease Modelling and Therapeutic Testing for Colorectal Cancer.
   Randall-Demllo S, Al-Qadami G, Raposo AE, Ma C, et al · · 2024 · cited 1× · PMID 39518102 · DOI 10.3390/cancers16213664
6. Tumor Organoid and Microenvironment Cocultures: Implications for Basic and Translational Cancer Research.
   Yang J, Cheng C, Luo W, He X, et al · · 2026 · PMID 41987851 · DOI 10.1002/mco2.70741
7. Advances in precision oncology using patient-derived organoids and functional biomaterials.
   Singh H, Mijakovic I, Singh P. · · 2025 · PMID 41098309 · DOI 10.3389/fcell.2025.1670328