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NCT02569801 · ClinicalTrials.gov registry record · Phase 2
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
A Phase 2 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT02569801: Clinical Trial Phase 2 study, sponsored by Genentech.
NCT02569801 is a Phase 2 study that was terminated before completion, run by Genentech. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02569801, a Phase 2 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.
Primary Outcome
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
Interventions
- DRUG Fulvestrant
- DRUG GDC-0810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-12-04 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 2 |
Why NCT02569801 stopped before completion
NCT02569801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT02569801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02569801 about?
NCT02569801 is a clinical study titled "A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy". The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI ...
What is the current status of trial NCT02569801?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-12-04. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT02569801?
The interventions under investigation include: Fulvestrant (DRUG), GDC-0810 (DRUG).
Who is sponsoring clinical trial NCT02569801?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02569801's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 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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