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NCT02860000 · ClinicalTrials.gov registry record · Phase 2
Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT02860000: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT02860000 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02860000, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study Summary
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.
Primary Outcome
For arm I, tumor response rate is defined as 100% times the number of patients who meet the criteria for CR or PR on 2 consecutive evaluations approximately 8 weeks apart during treatment with alisertib monotherapy divided by the number of patients who started alisertib monotherapy. For arm II, tumor response rate is defined as 100% times the number of patients who meet the criteria for CR or PR on 2 consecutive evaluations approximately 8 weeks apart during treatment with combination of alisert
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Fulvestrant
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2025-02-14 |
| Phase | Phase 2 |
What the finished NCT02860000 record still lists
NCT02860000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02860000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02860000 about?
NCT02860000 is a clinical study titled "Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer". This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone thera...
What is the current status of trial NCT02860000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2017-07-06. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT02860000?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Fulvestrant (DRUG), Alisertib (DRUG).
Who is sponsoring clinical trial NCT02860000?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02860000's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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