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NCT07590583 · ClinicalTrials.gov registry record · Phase 1
Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial
A Phase 1 study, sponsored by City of Hope Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07590583: Clinical Trial Phase 1 study, sponsored by City of Hope Medical Center.
NCT07590583 is a Phase 1 study that has not yet begun recruiting, run by City of Hope Medical Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07590583, a Phase 1 study, has not yet begun recruiting, sponsored by City of Hope Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This clinical trial tests the feasibility and utility of a biology guided therapy recommendations report to aid in determining treatment of hormone receptor positive breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). The biology guided therapy recommendations report is developed from testing a patients tumor tissue when they have progression to see what medications may work best and what medications the cancer may be resistant to based on their tumor biology. Patients and their doctor then receive that report with the suggested treatments. Receiving a biology guided therapy recommendations report may be a feasible and useable way to aid in treatment determination for hormone receptor positive advanced, unresectable or metastatic breast cancer.
Primary Outcome
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.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- OTHER Electronic Health Record Review
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-12-19 |
| Est. Completion | 2027-12-02 |
| Phase | Phase 1 |
What is known before NCT07590583 opens enrollment
NCT07590583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07590583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07590583 about?
NCT07590583 is a clinical study titled "Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial". This clinical trial tests the feasibility and utility of a biology guided therapy recommendations report to aid in determining treatment of hormone receptor positive breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body may have sp...
What is the current status of trial NCT07590583?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-12-19. Estimated completion is 2027-12-02.
What interventions are being tested in trial NCT07590583?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Electronic Health Record Review (OTHER).
Who is sponsoring clinical trial NCT07590583?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07590583's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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