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NCT02675231 · ClinicalTrials.gov registry record · Phase 2
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
NCT02675231: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT02675231 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02675231, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 237 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
Primary Outcome
PFS time was measured from the date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participa
Interventions
- DRUG Trastuzumab
- DRUG Fulvestrant
- DRUG Abemaciclib
- DRUG Standard of Care Single Agent Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2016-05-23 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 2 |
What the finished NCT02675231 record still lists
NCT02675231 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT02675231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02675231 about?
NCT02675231 is a clinical study titled "A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer". The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) loca...
What is the current status of trial NCT02675231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2016-05-23. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT02675231?
The interventions under investigation include: Trastuzumab (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG), Standard of Care Single Agent Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02675231?
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 NCT02675231's enrollment target sits among peer trials
237 255th of 2000 higher than 1,746 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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