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NCT03584009 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT03584009 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 103 participants.
The verdict
NCT03584009, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic Breast Cancer (MBC) who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks. As of 9th October 2020, participants in the Venetoclax + Fulvestrant arm, have all discontinued Venetoclax treatment and have continued on Fulvestrant treatment alone.
Interventions
- DRUG Venetoclax
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2021-05-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03584009
The ClinicalTrials.gov registry entry for NCT03584009 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT03584009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03584009 about?
NCT03584009 is a clinical study titled "A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy". This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic Breast Cancer (MBC) who experienced disease recurrence or progression d...
What is the current status of trial NCT03584009?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2018-09-06. Estimated completion is 2021-05-06.
What interventions are being tested in trial NCT03584009?
The interventions under investigation include: Venetoclax (DRUG), Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT03584009?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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