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NCT06105684 · ClinicalTrials.gov registry record · Phase 2
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06105684: Recruiting Phase 2 study of Metastatic Breast Cancer, sponsored by University of Alabama at Birmingham.
NCT06105684 is a Phase 2 study of Metastatic Breast Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06105684, a Phase 2 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
Primary Outcome
Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression of disease will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee; version 1.1. Patients will be evaluated for response every 12 weeks per RECIST Criteria.
Conditions Studied
Interventions
- DRUG Capecitabine Pill
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT06105684 shows while recruiting
NCT06105684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Capecitabine Pill is the first listed.
NCT06105684 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06105684 about?
NCT06105684 is a clinical study titled "Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer". This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
What is the current status of trial NCT06105684?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-02-14. Estimated completion is 2028-06.
What conditions does trial NCT06105684 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT06105684?
The interventions under investigation include: Capecitabine Pill (DRUG).
Who is sponsoring clinical trial NCT06105684?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06105684 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06105684's enrollment target sits among peer trials
40 93rd of 139 higher than 45 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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