Organ Culture for Endocrine Resistant Next Line: A Treatment Selection Study in Metastatic Breast Cancer

NCT07895160 · tracked via the Priya Life Science Israel tracker

Sponsor

Tel-Aviv Sourasky Medical Center

Phase

Not applicable

Started

2024-06-14

Last updated

2026-10-26

Condition(s) studied

Metastatic Breast CancerHormon Receptor Positive Breast Cancer

Investigational drug(s) / intervention(s)

cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay

cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay: Fresh tumor tissue obtained by biopsy will undergo functional drug sensitivity testing using the cResponse ex vivo organ culture (EVOC) platform. Tumor samples will be exposed to a panel of anticancer agents, and treatment-specific response scores will be generated. The assay results will guide selection of the next available systemic anticancer treatment.

Study summary

This study evaluates whether testing fresh tumor samples outside the body can help guide treatment selection for patients with hormone receptor-positive, HER2-negative metastatic breast cancer that has progressed during endocrine therapy.

A biopsy sample from each participant will be tested using an ex vivo organ culture (EVOC) platform, which preserves the tumor tissue and allows researchers to assess its response to different anticancer treatments. The results will be used to help select the participant's next systemic treatment.

The main objective is to evaluate the proportion of patients whose cancer responds to treatment selected using this approach. The study will also assess how long the cancer remains controlled, overall survival, and the relationship between laboratory test results and clinical outcomes.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients progressing on endocrine therapy, with or without biological therapy, who are candidates for their first non-endocrine-based line of treatment. * Patients expected to receive treatment for metastatic breast cancer within the coming weeks. * Age 18 years or older. * Life expectancy of at least 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Exclusion Criteria: * Chemotherapy within 3 weeks before biopsy or aspiration. * Any severe concurrent disease that, in the investigator's judgment, makes the patient unsuitable for study participation. * Positive test for acquired immunodeficiency syndrome (AIDS). * Positive hepatitis B or hepatitis C testing indicating acute or chronic infection. * Pregnancy or breastfeeding. * Treatment with another investigational drug within 14 days before study entry. * Inability to exercise judgment.

Primary outcome measure(s)

Objective Response Rate (ORR) — From initiation of assay-guided treatment through study completion, an estimated average of 1 year.
The proportion of evaluable participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1 following systemic anticancer treatment selected using the cResponse ex vivo organ culture (EVOC) drug sensitivity assay. The response rate will be calculated among participants with an assay result indicating sensitivity to at least one tested treatment, as specified in the study protocol. Tumor response will be assessed approximately every 8 weeks until disease progression or treatment discontinuation.

Trial sites (1)

Facility	City	Region	Status
Tel Aviv Sourasky Medical Center	Tel Aviv	Israel	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07895160 on ClinicalTrials.gov ↗ ← All trials in Israel