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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 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 318 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01437566
The ClinicalTrials.gov registry entry for NCT01437566 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fulvestrant is the first listed.
NCT01437566 reports 0 study locations.
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.
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