Breast cancer.
Nadia Harbeck, Michael Gnant
https://pubmed.ncbi.nlm.nih.gov/27865536Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-03-18
306
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are investigating breast cancer, focusing on patients who lack targeted therapies such as those with triple-negative breast cancer or those experiencing relapse after previous treatments. The study aims to develop tools to predict how patients respond to chemotherapy and to identify related biomarkers. Patient-derived organoids (PDOs), which are lab-grown tumor models preserving key tumor features, are being explored as a promising method for personalized treatment development. The study involves creating and maintaining a living biobank of PDOs that represent various breast cancer subtypes, including ER/PR+, HER2+, and triple-negative breast cancer. These PDOs will be used to assess their similarity to original tumor samples and to test their sensitivity to new and existing therapeutic agents, including splicing-targeting treatments and potential combinations with immunotherapies. The research includes both prospective and retrospective analysis over periods of 36 to 42 months. Participants will be women aged 18 to 70 years diagnosed with primary breast cancer and eligible for tumor surgery. The study evaluates the histological and molecular match between PDOs and patient tumors, as well as PDO responses to treatments through laboratory experiments. Researchers will use these findings to understand chemotherapy resistance and explore new treatment options. The overall study participation includes tumor sample collection and laboratory analysis without direct treatment intervention, and it will continue through mid-2027 for comprehensive data collection and analysis.
CONDITIONS
Breast Cancer Subtype Characterization Through Patient's Derived Organoids.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At time of surgery
Participants provide tumor samples during surgical tumor removal to develop patient-derived organoids (PDOs) for breast cancer subtype characterization.
1 visit (in-person)
Duration - Up to 42 months
Participants’ PDOs are observed over time to evaluate histological and molecular conformity and sensitivity to therapeutic agents, supporting prospective and retrospective studies on breast cancer chemoresistance.
Total: 1 location
1
IRCCS Fondazione Policlinico A. Gemelli
Roma, Italy, 00168
Actively Recruiting
A
Alba Di Leone, Doc
C
Chiara Naro, Doc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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