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OCEAN: Organ Culture for Endocrine Resistant Next Line - Treatment Selection Based on Fresh Tumor Samples in Metastatic Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Breast Cancer Research Coordinator
hananm@tlvmc.gov.il
97236974092
Time Frame
Start Date: 2024-06-14
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 39
Treatments
Experimental: EVOC-Guided Treatment Selection
Participants with endocrine-resistant metastatic breast cancer will undergo tumor biopsy and functional drug sensitivity testing using the cResponse ex vivo organ culture (EVOC) platform. The next systemic anticancer treatment will be selected based on the assay results, with preference for the highest-scoring clinically available treatment.
Related Therapeutic Areas
Sponsors
Leads: Tel-Aviv Sourasky Medical Center

This content was sourced from clinicaltrials.gov