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ENDORSE Trial: Biology-Guided Therapy for Advanced Hormone Receptor-Positive Breast Cancer

This study, called ENDORSE, is looking at a new way to help doctors choose the best treatments for advanced hormone receptor-positive breast cancer that has spread or cannot be removed by surgery. Researchers will analyze your tumor tissue to create a "biology-guided therapy recommendations report." This report aims to show which standard treatments might work best and which ones your cancer might be resistant to. The main goal is to see if this report can be created quickly enough (within 30 days) to be useful for patients. This study is for adults aged 18 and older with this type of breast cancer. It will help us understand if using this detailed tumor analysis can lead to better treatment choices.

Study design
This study is an interventional trial with a planned enrollment of 20 participants. It focuses on analyzing tumor tissue to guide treatment recommendations.
What's involved
You would undergo a tumor biopsy, blood sample collection, bone scan, and CT scan. Your electronic health records would also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, turnaround time, is measured at up to 30 days. Other follow-up details are not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07590583

Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~20 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionBone ScanComputed TomographyElectronic Health Record ReviewMagnetic Resonance Imaging

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Turnaround time (feasibility)
Measured over Up to 30 days.

Conditions

Advanced Hormone Receptor-Positive Breast Carcinoma
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Hormone Receptor-Positive Breast Carcinoma
Unresectable Hormone Receptor-Positive Breast Carcinoma

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Breast Carcinoma

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Irene M Kang · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Irene M. Kang
[email protected]
844-756-2047
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must speak English
Documented informed consent of the participant and/or legally authorized representative.
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 years
Patients must have histologically confirmed, unresectable or metastatic hormone receptor positive, HER2 breast cancer. Hormone receptor positive is defined as estrogen receptor \>= 10% and/or progesterone receptor \>= 10%. Her2 negative per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
Patient must have disease progression during or after prior endocrine therapy meeting one of the following criteria:
Disease progression on 1st line endocrine therapy for advanced/metastatic breast cancer.
Disease progression on or within 2 years of completion of treatment with a CDK4/6i in the adjuvant setting for early- stage breast cancer
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Patient must have at least one lesion amenable to percutaneous core
Clinically appropriate for biopsy

Exclusion

Prior treatment in the metastatic setting with capecitabine, phosphoinositide 3 kinase (PI3K) inhibitor, mechanistic target of rapamycin (mTOR) inhibitor, protein kinase B (Akt) inhibitor, selective estrogen receptor degrader (SERD), or HER2-targeted therapy, including neratinib
Known or untreated, or active, brain or leptomeningeal metastases that are deemed inappropriate to pursue therapy guided by systems medicine approach. Enrolled patients may receive radiation or other loco regional therapy prior to initiating systemic therapy on study. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors not requiring active therapy
Life expectancy \< 1 year
Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

What this trial measures

  • Turnaround time (feasibility)Up to 30 days.

    Report consists of an Evaluation of Novel Data-driven Outcomes via Response-guided Systems Medicine in Hormone Receptor-positive Advanced Breast Cancer (ENDORSE) signature score, MTOR signature score and status of other Food and Drug Administration approved biomarkers, including ESR1 mutations, PIK3CA mutations and HER2 mutation/expression). The turn-around time will be summarized by the range, mean, median, and standard deviation.