Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Sermonix Pharmaceuticals. The registered enrollment target is 100 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03781063
The ClinicalTrials.gov registry entry for NCT03781063 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sermonix Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT03781063 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.