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NCT04031885 · ClinicalTrials.gov registry record · Phase 4
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
A Phase 4 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT04031885: Clinical Trial Phase 4 study, sponsored by Eli Lilly and Company.
NCT04031885 is a Phase 4 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04031885, a Phase 4 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Primary Outcome
ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm \[intent-to-treat (ITT) population\], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD)
Interventions
- DRUG Fulvestrant
- DRUG Abemaciclib
- DRUG Standard Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-08-14 |
| Est. Completion | 2020-08-11 |
| Phase | Phase 4 |
Why NCT04031885 stopped before completion
NCT04031885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT04031885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04031885 about?
NCT04031885 is a clinical study titled "A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer". The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to int...
What is the current status of trial NCT04031885?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2019-08-14. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT04031885?
The interventions under investigation include: Fulvestrant (DRUG), Abemaciclib (DRUG), Standard Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT04031885?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04031885's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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