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NCT06525766 · ClinicalTrials.gov registry record · Phase 2
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
A Phase 2 study of Metastatic Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT06525766: Recruiting Phase 2 study of Metastatic Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
NCT06525766 is a Phase 2 study of Metastatic Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 35 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06525766, a Phase 2 study of Metastatic Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.
Primary Outcome
Will be assessed by the proportion of patients (%) who are able to receive 2 or more cycles of AT with capecitabine divided by the total number of patients who have entered the AT phase of treatment (have stable or responsive disease).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Bone Scan
Study Locations (1)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2030-10-15 |
| Phase | Phase 2 |
What NCT06525766 shows while recruiting
NCT06525766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (83% lower).
The record links to 4 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06525766 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06525766 about?
NCT06525766 is a clinical study titled "Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer". This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastati...
What is the current status of trial NCT06525766?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2025-10-01. Estimated completion is 2030-10-15.
What conditions does trial NCT06525766 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT06525766?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT06525766?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06525766 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06525766's enrollment target sits among peer trials
35 99th of 139 higher than 41 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer 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.
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