Personalized treatment after endocrine therapy failure in metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm pilot study uses an ex vivo organ culture (EVOC) platform to test a panel of anticancer drugs on freshly obtained tumor tissue from patients whose metastatic breast cancer has become resistant to endocrine therapy. The drug sensitivity results guide the selection of the patient’s next systemic treatment, which is then given and monitored. Primary endpoint is objective tumor response, with secondary endpoints including progression-free and overall survival, clinical benefit, and the link between lab drug sensitivity and clinical outcomes. The study uses a two-stage design to allow early stopping if predefined response criteria are not met. Participation involves biopsy, EVOC testing, treatment based on results, and regular clinical and radiologic assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tel Aviv Sourasky Medical Center
  Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Breast Cancer Research Coordinator
• Email: hananm@tlvmc.gov.il
• Phone: 97236974092

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.