Metastatic Breast CancerOCEANNCT07895160
Organ Culture for Endocrine Resistant Next Line: A Treatment Selection Study in Metastatic Breast Cancer
A study testing cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay in people with Metastatic Breast Cancer and Hormon Receptor Positive Breast Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Hormon Receptor Positive Breast Cancer
- What is being tested?
- cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jun 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Breast Cancer Research Coordinator, 97236974092, hananm@tlvmc.gov.il
About this study
Official title: OCEAN: Organ Culture for Endocrine Resistant Next Line - Treatment Selection Based on Fresh Tumor Samples in Metastatic Breast Cancer
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.
Read the detailed 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.
- Being tested
- cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay
- Keywords
- Endocrine-resistant breast cancer, Ex vivo organ culture, Functional drug sensitivity testing, Personalized treatment selection, Precision oncology, OCEAN study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity AssayDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| EVOC-Guided Treatment Selection | Experimental | 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. Receives: Diagnostic Test: cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: From initiation of assay-guided treatment through study completion, an estimated average of 1 year.
Secondary outcomes (5)
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from initiation of assay-guided systemic anticancer treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Disease progression will be assessed approximately every 8 weeks. Participants without documented progression or death will be censored at the date of their last adequate disease assessment.
Measured: From initiation of assay-guided treatment through study completion, an estimated average of 1 year.
Overall Survival (OS)
Overall survival (OS) is defined as the time from initiation of assay-guided systemic anticancer treatment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Measured: From initiation of assay-guided treatment until death from any cause or end of follow-up, up to 24 months.
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) is defined as the proportion of evaluable participants achieving complete response (CR), partial response (PR), or stable disease (SD) of the protocol-defined minimum duration, according to RECIST version 1.1, following assay-guided systemic anticancer treatment. Tumor response will be assessed approximately every 8 weeks until disease progression or treatment discontinuation.
Measured: From initiation of assay-guided treatment through study completion, an estimated average of 1 year.
Correlation Between cResponse Drug Sensitivity Score and Clinical Tumor Response
Correlation between the quantitative drug sensitivity score (range: 1-100; unitless, with higher scores indicating greater predicted drug sensitivity), generated by the cResponse ex vivo organ culture (EVOC) assay using a proprietary algorithm, and observed clinical tumor response to the selected treatment, assessed according to RECIST version 1.1. Clinical response will be categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The correlation will be quantified using Spearman's rank correlation coefficient (range: -1 to +1; unitless).
Measured: From assay testing through study completion, an estimated average of 1 year.
Second Progression-Free Survival (PFS2)
Second progression-free survival (PFS2) is defined as the time from initiation of assay-guided systemic anticancer treatment to the second documented disease progression, occurring during or after subsequent anticancer treatment, or death from any cause, whichever occurs first. Participants without a documented PFS2 event will be censored at the date of their last adequate disease assessment, according to the study protocol.
Measured: From initiation of assay-guided treatment through study completion, an estimated average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start14 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, non-randomized pilot study evaluating treatment selection guided by the cResponse ex vivo organ culture (EVOC) functional drug sensitivity assay in patients with endocrine-resistant metastatic breast cancer. All participants will undergo tumor sampling for functional drug sensitivity testing, and the results will guide the selection of their next available systemic anticancer treatment. There is no concurrent control group.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895160
- Sponsor's protocol ID
- 0619-23-TLV
- Acronym
- OCEAN
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Study data will be maintained in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory approvals. Aggregate study results may be published or presented in scientific publications and conferences.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCEAN: Organ Culture for Endocrine Resistant Next Line - Treatment Selection Based on Fresh Tumor Samples in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07895160
- Acronym / sponsor ID
- OCEAN / 0619-23-TLV
- Keywords
- Endocrine-resistant breast cancer, Ex vivo organ culture, Functional drug sensitivity testing, Personalized treatment selection, Precision oncology, OCEAN study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, non-randomized pilot study evaluating treatment selection guided by the cResponse ex vivo organ culture (EVOC) functional drug sensitivity assay in patients with endocrine-resistant metastatic breast cancer. All participants will undergo tumor sampling for functional drug sensitivity testing, and the results will guide the selection of their next available systemic anticancer treatment. There is no concurrent control group.
| Arm | Type | Receives |
|---|---|---|
| EVOC-Guided Treatment Selection | Experimental | Diagnostic Test: cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity AssayParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity AssayFresh 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. | Diagnostic test | EVOC-Guided Treatment Selection |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From initiation of assay-guided treatment through study completion, an estimated average of 1 year.
Overall Survival (OS)
Time frame: From initiation of assay-guided treatment until death from any cause or end of follow-up, up to 24 months.
Clinical Benefit Rate (CBR)
Time frame: From initiation of assay-guided treatment through study completion, an estimated average of 1 year.
Correlation Between cResponse Drug Sensitivity Score and Clinical Tumor Response
Time frame: From assay testing through study completion, an estimated average of 1 year.
Second Progression-Free Survival (PFS2)
Time frame: From initiation of assay-guided treatment through study completion, an estimated average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Study data will be maintained in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory approvals. Aggregate study results may be published or presented in scientific publications and conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cResponse Ex Vivo Organ Culture (EVOC) Drug Sensitivity Assay in people with Metastatic Breast Cancer and Hormon Receptor Positive Breast Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Breast Cancer Research Coordinator (97236974092, hananm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From initiation of assay-guided treatment through study completion, an estimated average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.