Overview
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.
Description
OCEAN is a prospective, single-arm, interventional pilot study evaluating the feasibility and clinical utility of treatment selection guided by ex vivo drug sensitivity testing in patients with endocrine-resistant, hormone receptor-positive, HER2-negative or HER2-low metastatic breast cancer.
Fresh tumor tissue obtained through biopsy will be processed using an ex vivo organ culture (EVOC) platform. Tumor samples will be maintained in culture and exposed to a panel of anticancer agents to assess treatment-specific responses. Drug sensitivity results will be used to guide the selection of the next systemic anticancer treatment.
Participants will receive the selected treatment and undergo clinical and radiological assessments according to the study protocol.
The primary endpoint is objective response rate, defined as the proportion of participants achieving a complete or partial response. Secondary endpoints include progression-free survival, overall survival, clinical benefit rate, and the association between ex vivo drug sensitivity and clinical treatment outcomes.
The study aims to investigate whether functional testing of fresh tumor samples can support more individualized treatment selection after progression on endocrine therapy.
The study uses a Simon's two-stage design with an interim analysis after enrollment of the first 19 participants. Based on the prespecified response criteria, the study may stop after the first stage or proceed to enroll an additional 20 participants, for a maximum total enrollment of 39 participants.
Eligibility
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.
