Personalized therapy using patient-derived organoids for metastatic breast cancer
Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar: Proof-of-concept Study
This study is testing whether using mini versions of a patient's breast tumor can help find the best treatment options for people with metastatic breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06459791 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves taking a biopsy from a breast tumor to create patient-derived organoids (PDOs), which serve as avatars for personalized treatment. A drug screening will be conducted on these organoids to determine which therapies are most effective for the individual patient. Based on the results, a personalized tumorogram will be generated, predicting the tumor's sensitivity to various drugs. Patients will continue standard care while awaiting their tumorogram results, and treatment recommendations will be made by a multidisciplinary committee based on the findings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced breast cancer, specifically those with triple-negative or hormone receptor-positive breast cancer that has progressed after hormone therapy.
Not a fit: Patients with more than three lines of chemotherapy in the advanced setting or those with progressive brain or leptomeningeal metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and tailored treatments for patients with metastatic breast cancer.
How similar studies have performed: While personalized medicine approaches using organoids are emerging, this specific methodology is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient over 18 years of age 2. Advanced breast cancer 3. Triple-negative phenotype (HR-/HER2-) or HR+/HER2- after hormone resistance (progression after treatment with hormone therapy + CDK4/6 inhibitor) 4. Tumor measurable according to RECISTv1.1 criteria, accessible to biopsy 5. Performans Status 0-1 Exclusion Criteria: 1. More than 3 lines of chemotherapy in the advanced setting (excluding hormone therapy/CDK4/6 inhibitor) 2. Progressive brain metastases 3. Leptomeningeal metastasis
Where this trial is running
Paris and 2 other locations
- Institut Curie — Paris, France (Recruiting)
- Hôpital Saint-Louis - AP-HP Senopole — Paris, France (Not_yet_recruiting)
- Institut Curie — Saint-Cloud, France (Recruiting)
Study contacts
- Principal investigator: Luc CABEL, MD — Institut Curie
- Study coordinator: Luc CABEL, MD
- Email: drci.promotion@curie.fr
- Phone: +33 1 56 24 55 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.