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NCT03781063 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
A Phase 2 study, sponsored by Sermonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03781063: Completed Phase 2 study, sponsored by Sermonix Pharmaceuticals.
NCT03781063 is a Phase 2 study that has completed, run by Sermonix Pharmaceuticals. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03781063, a Phase 2 study, has completed, sponsored by Sermonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).
Primary Outcome
PFS is defined as the interval from the date of randomization to the earlier date of first documented radiographic progression or death due to any cause
Interventions
- DRUG Fulvestrant
- DRUG Lasofoxifene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 2 |
What the finished NCT03781063 record still lists
NCT03781063 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT03781063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03781063 about?
NCT03781063 is a clinical study titled "Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation". This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an ar...
What is the current status of trial NCT03781063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2019-09-20. Estimated completion is 2025-05-08.
What interventions are being tested in trial NCT03781063?
The interventions under investigation include: Fulvestrant (DRUG), Lasofoxifene (DRUG).
Who is sponsoring clinical trial NCT03781063?
This trial is sponsored by Sermonix Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03781063's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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