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NCT06062498 · ClinicalTrials.gov registry record · Phase 2
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
A Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor-positive Breast Cancer, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
- 1
- Study location
NCT06062498: Recruiting Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor-positive Breast Cancer, sponsored by Northwestern University.
NCT06062498 is a Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor-positive Breast Cancer that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 174 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06062498, a Phase 2 study of Metastatic Breast Cancer and Estrogen Receptor-positive Breast Cancer, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
- 1
- Study location
Study Summary
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting. The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.
Primary Outcome
The primary endpoint of PFS for elacestrant or combination therapy (elacestrant and either palbociclib, abemaciclib, or ribociclib) will involve calculation of the progression-free survival time as the time that elapses between time of treatment initiation and first documented disease progression or death from any cause (whichever comes first). For PFS analysis, disease progression is defined as progressive disease (PD) per RECIST v1.1. The PFS results from the two treatment arms will be compare
Conditions Studied
Interventions
- DRUG elacestrant, palbociclib, abemaciclib, ribociclib
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
What NCT06062498 shows while recruiting
NCT06062498 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (15% lower).
The record links to 4 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which elacestrant, palbociclib, abemaciclib, ribociclib is the first listed.
NCT06062498 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06062498 about?
NCT06062498 is a clinical study titled "Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer". Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nat...
What is the current status of trial NCT06062498?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2023-09-29. Estimated completion is 2027-07-01.
What conditions does trial NCT06062498 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv.
What interventions are being tested in trial NCT06062498?
The interventions under investigation include: elacestrant, palbociclib, abemaciclib, ribociclib (DRUG).
Who is sponsoring clinical trial NCT06062498?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06062498 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06062498's enrollment target sits among peer trials
174 38th of 139 higher than 102 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer 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.
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