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NCT01437566 · ClinicalTrials.gov registry record · Phase 2
Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 318
- Enrollment target
NCT01437566: Completed Phase 2 study, sponsored by Genentech.
NCT01437566 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 318 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (139% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437566, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 318 participants
- Enrollment target
Study Summary
This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.
Interventions
- DRUG Fulvestrant
- DRUG GDC-0980
- DRUG GDC-0941
- DRUG GDC-0941 Matching Placebo
- DRUG GDC-0980 Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01437566 record still lists
NCT01437566 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (139% higher).
The record links to 0 conditions, and to 5 interventions - of which Fulvestrant is the first listed.
NCT01437566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01437566 about?
NCT01437566 is a clinical study titled "Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy". This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or w...
What is the current status of trial NCT01437566?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 318 participants. The study started on 2011-10. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01437566?
The interventions under investigation include: Fulvestrant (DRUG), GDC-0980 (DRUG), GDC-0941 (DRUG), GDC-0941 Matching Placebo (DRUG), GDC-0980 Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT01437566?
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 NCT01437566's enrollment target sits among peer trials
318 153rd of 2000 higher than 1,846 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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