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Completed Phase 2 Interventional

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy

ClinicalTrials.gov ID: NCT01437566

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.

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ClinicalTrials.gov public records Last synced Oct 24, 2026, 2:40 PM EDT

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
Lead sponsor
Genentech, Inc.
Industry
Enrollment
318 participants

Conditions and interventions

Conditions

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
Oct 2011 (Type not available)
Primary completion
Apr 2016 (Actual)
Completion
Apr 2016 (Actual)
Last update posted
Nov 2, 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 2, 2016 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01437566 live on ClinicalTrials.gov.

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