Making organoids from breast tumors before and after neoadjuvant chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls people with invasive breast cancer who are scheduled for neoadjuvant chemotherapy and surgery. Tumor tissue will be collected before and after treatment to create patient-derived organoid (PDO) cultures that model each patient's tumor. Researchers will analyze biomarkers released by the organoids, especially those carried in extracellular vesicles, and compare them with tumor tissue and blood samples collected before, during, and after therapy. Biomarker patterns will be correlated with pathological complete response versus residual disease to identify potential predictors of treatment outcome.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who have already undergone prior chemotherapy treatments;
* Patients without a proven cyto-histological diagnosis of breast carcinoma;
* Subjects affected by other solid tumors besides the breast lesion.

Where it's running

• Istituti Clinici Scientifici Maugeri
  Pavia, Pv, Italy Recruiting

Study contacts

• Study coordinator: Fabio CorsI
• Email: fabio.corsi@icsmaugeri.it
• Phone: +390382592272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.