Clinical trial NCT06315868: Breast Cancer Subtype Characterization Through Patient's Derived Organoids.
Official title: Breast Cancer Subtype Characterization Through Patient's Derived Organoids". (BCinsightPDO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Organoids
Keywords: breast cancer
new drugs
organoids
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible population includes women diagnosed with primary BC, eligible for surgical resection of the tumor according to national and international guidelines. Each case will be discussed, before surgery, at the multidisciplinary tumor board for BC of the Fondazione Policlinico A. Gemelli, IRCCS.

All women will be required to sign written informed consent to enter the study. The study design has considered following inclusion criteria: age between 18 and 70 years; newly diagnosed breast neoplasms, tumor size of at least 1.5 cm diameter.

Brief summary: Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies, such as TNBC, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies.

The refinement of 3D-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (PDO), which preserve histologic, genomic and transcriptomic features of primary tumors. PDO allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies

Detailed description: PDO have been shown to efficiently recapitulate ex-vivo the in vivo response to hormonal treatment of BC patients. These observations point to PDO as potential valuable tools for a rapid, personalized prospective evaluation of patient-specific chemo-sensitivity. Moreover, PDO can represent a valuable ex-vivo platform for screening new treatments, or combination of current treatments, in a medium-to-high-throughput fashion. Thus, development of a stable collection of PDO representing the heterogeneity of BC subtypes, including the evolution of recurrent disease, represents an extremely useful resource for both prospective and retrospective studies aimed at understanding the molecular phenotype associated with chemoresistance.

Eligibility criteria: Inclusion Criteria:

* women diagnosed with primary BC, eligible for surgical resection of the tumor according to national and international guidelines.

age between 18 and 70 years; newly diagnosed breast neoplasms, tumor size of at least 1.5 cm diameter.

Exclusion Criteria:

breast cancer diagnosed during pregnancy, neoadiuvant chemotherapy

Primary outcomes:
measure: evaluate the histological and molecular conformity (yes/no) between PDO and matched primary and/or recurrent BC sample, in order to develop a live biobank of ER/PR+, HER2+ and TNBC PDO.
timeFrame: 36 months
measure: evaluate the sensitivity of ER/PR+, HER2+ and TNBC PDO to novel therapeutic agents in clinical trials for BC or other cancer types
timeFrame: 42 months
Secondary outcomes:
measure: test the sensitivity of PDO to splicing-targeting treatments, either alone or in combination with other therapies
timeFrame: 42 months
measure: test the synergizing effects of agents splicing-targeting treatments to immunotherapies by co-culture experiments with autologous immune cells
timeFrame: 42 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS Fondazione Policlinico A. Gemelli
Study officials:
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