Personalized therapy using patient-derived organoids for metastatic breast cancer
Official title: Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar: Proof-of-concept Study
Run by Institut Curie · NCT06459791 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Paris and 2 other locations) |
| Status | Recruiting |
| Started | December 6, 2024 |
| Main results expected | December 15, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT06459791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While personalized medicine approaches using organoids are emerging, this specific methodology is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
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 it's running
-
Institut Curie
Paris, France Recruiting -
Institut Curie
Saint-Cloud, France Recruiting -
Hôpital Saint-Louis - AP-HP Senopole
Paris, France Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PRT13722 in advanced HR+/HER2- breast cancer
This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.
-
Personalized treatment after endocrine therapy failure in metastatic breast cancer
The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.
-
SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer
This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.
-
SMP-656 in HER2-positive advanced breast cancer after ADC therapy
This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.
-
Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure
This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.
-
T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer
This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.