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NCT03659136 · ClinicalTrials.gov registry record · Phase 2
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT03659136: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03659136 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03659136, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.
Primary Outcome
Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions
Interventions
- DRUG Placebo
- DRUG Exemestane
- DRUG Everolimus
- DRUG Xentuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 2 |
What the finished NCT03659136 record still lists
NCT03659136 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03659136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03659136 about?
NCT03659136 is a clinical study titled "The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread". The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.
What is the current status of trial NCT03659136?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2018-11-28. Estimated completion is 2022-05-11.
What interventions are being tested in trial NCT03659136?
The interventions under investigation include: Placebo (DRUG), Exemestane (DRUG), Everolimus (DRUG), Xentuzumab (DRUG).
Who is sponsoring clinical trial NCT03659136?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03659136's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 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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