NCT07260188Recruiting
Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy
Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
The aim of this study is to establish patient-derived organoid (PDO) and tumor tissue cultures from breast cancer patients, in order to create personalized, accurate, and reliable preclinical models capable of providing information on the diverse biomolecular portraits of breast cancer. These models may also be used to predict the achievement of pathological complete response after neoadjuvant chemotherapy (NAC) treatment, study the biological, molecular, genetic, and microenvironmental characteristics of each tumor, and isolate tumor-derived extracellular vesicles from the PDOs and tissues and analyze them as potential biomarkers of response to NAC.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 23 Sept 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07260188
What you commit to
- Study type: Observational
- Planned participants: 240
- From 23 Sept 2025 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have already undergone prior chemotherapy treatments;
Other
- Patients without a proven cyto-histological diagnosis of breast carcinoma;
- Subjects affected by other solid tumors besides the breast lesion.
Who the study is looking for
- Female subjects;
- Confirmed diagnosis of breast heteroplasia
- Age 1\>= 8 years;
- Indication for neoadjuvant chemotherapy;
- Patients willing to follow the usual oncological follow-up;
- Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy;
- Subjects who agree to participate in the study by signing and dating the Informed Consent form.
Age in the registry: 18 years to - · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.