Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
Public ClinicalTrials.gov record NCT01437566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01437566
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 318 participants
Conditions and interventions
Conditions
Interventions
- Fulvestrant Drug
- GDC-0941 Drug
- GDC-0941 Matching Placebo Drug
- GDC-0980 Drug
- GDC-0980 Matching Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2011
- Primary completion
- Mar 31, 2016
- Completion
- Mar 31, 2016
- Last update posted
- Nov 1, 2016
2011 – 2016
United States locations
- U.S. sites
- 41
- U.S. states
- 16
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35294 | — |
| Not listed | Hayward | California | 94545 | — |
| Not listed | Oakland | California | 94611 | — |
| Not listed | Roseville | California | 95661 | — |
| Not listed | Sacramento | California | 95825 | — |
| Not listed | San Francisco | California | 94115 | — |
| Not listed | San Jose | California | 95119 | — |
| Not listed | Santa Clara | California | 95051 | — |
| Not listed | South San Francisco | California | 94080 | — |
| Not listed | Vallejo | California | 94589 | — |
| Not listed | Walnut Creek | California | 94596 | — |
| Not listed | Washington D.C. | District of Columbia | 20010 | — |
| Not listed | Boca Raton | Florida | 33428 | — |
| Not listed | Fort Myers | Florida | 33916 | — |
| Not listed | Jacksonville | Florida | 32224 | — |
| Not listed | St. Petersburg | Florida | 33705 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Not listed | Joliet | Illinois | 60435 | — |
| Not listed | Peoria | Illinois | 61615 | — |
| Not listed | Wichita | Kansas | 67214-3728 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Boston | Massachusetts | 02215 | — |
| Not listed | St Louis | Missouri | 63128 | — |
| Not listed | Basking Ridge | New Jersey | 07920 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Commack | New York | 11725 | — |
| Not listed | New York | New York | 10065 | — |
| Not listed | Rockville Centre | New York | 11570 | — |
| Not listed | Sleepy Hollow | New York | 10591 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Chattanooga | Tennessee | 37404 | — |
| Not listed | Germantown | Tennessee | 38138 | — |
| Not listed | Nashville | Tennessee | 37211 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | Houston | Texas | 77030-4095 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Tyler | Texas | 75702 | — |
| Not listed | Richmond | Virginia | 23226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01437566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 1, 2016 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01437566 live on ClinicalTrials.gov.