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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: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT03584009 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. 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
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.
Primary Outcome
Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR \>= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neith
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 |
Why NCT03584009 stopped before completion
NCT03584009 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 2 interventions - of which Venetoclax is the first listed.
NCT03584009 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03584009'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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