A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer

April 21, 2017 updated by: Genentech, Inc.

A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer

This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital;North Coast Cancer Institute
      • Wahroonga, New South Wales, Australia, 2076
        • Sydney Haematology & Oncology Clinic
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle; Medical Oncology
      • Wodonga, New South Wales, Australia, 3690
        • Border Medical Oncology
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Mackay, Queensland, Australia, 4740
        • Mater Adult Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Center Research
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Hospital; Oncology
      • Frankston, Victoria, Australia, 3199
        • Peninsula and South Eastern Haematology and Oncology Grou
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital; Medical Oncology
  • Austria
      • Graz, Austria, 8036
        • Lkh-Univ. Klinikum Graz
      • Salzburg, Austria, 5020
        • LKH - Universitätsklinikum der PMU Salzburg
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen
      • Wien, Austria, 1130
        • Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Mons, Belgium, 7000
        • CHU Ambroise Pare
      • Namur, Belgium, 5000
        • Clinique Ste-Elisabeth
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Czechia
      • Brno, Czechia, 613 00
        • Fakultni nemocnice Brno
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Liberec, Czechia, 460 63
        • Krajska Nemocnice Liberec A.S.
      • Pardubice, Czechia, 532 03
        • Multiscan s.r.o.
      • Prague, Czechia, 180 01
        • Nemocnice Na Bulovce
      • Praha 2, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice V Praze
      • Praha 4 - Krc, Czechia, 140 59
        • Thomayerova nemocnice
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala d Oncologia Hospital Duran i Reynals
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaén
      • Madrid, Spain, 28050
        • START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
      • Madrid, Spain, 28009
        • Hospital General Univ. Gregorio Maranon
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Catala d´Oncologia Hospital Germans Trias i Pujol
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, E1 2EF
        • Barts Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals City Campus
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
  • United States
    • Arizona
      • Sedona, Arizona, United States, 86336
        • Arizona Oncology Associates, PC - NAHOA
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center
      • Encinitas, California, United States, 92008
        • California Cancer Associates for Research & Excellence, Inc.
      • Hayward, California, United States, 94545
        • Kaiser Permanente - Hayward
      • Oakland, California, United States, 94611
        • Kaiser Permanente - Oakland
      • Pleasant Hill, California, United States, 94523
        • Bay Area Cancer Research Group, LLC
      • Roseville, California, United States, 95661
        • Kaiser Permanente Medical Center - Roseville
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Sacramento Medical Center
      • San Francisco, California, United States, 94115
        • Kaiser Permanente - San Francisco (2238 Geary)
      • San Francisco, California, United States, 94115
        • University of California at San Francisco
      • San Jose, California, United States, 95119
        • Kaiser Permanente - San Jose
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente - Santa Clara
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente - South San Francisco
      • Vallejo, California, United States, 94589
        • Kaiser Permanente - Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente - Walnut Creek
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Orange Park, Florida, United States, 32073
        • Cancer Specialists of North Florida
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology - Oncology Associates of Treasure Coast
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Memorial Hospital
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology; Associates, Ltd.
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Hematology Oncology Clinic
      • Metairie, Louisiana, United States, 70006
        • Metairie Oncologist, LLC
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Brookline, Massachusetts, United States, 02445
        • Beth Israel Deaconess Med Ctr
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Billings, Missouri, United States, Montana
        • Billings Clinic Cancer Center-CCD PRIME
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists; Oncology Hematology West, PC
    • New York
      • Lake Success, New York, United States, 11042
        • ProHEALTH Care Associates LLP
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
      • Canton, Ohio, United States, 44710
        • Aultman Hospital; Aultman Hospital Cancer Center
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Oncology Institute
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Hematology and Oncology Associates of Sc
    • Texas
      • Austin, Texas, United States, 78701
        • Shivers Cancer Center at University Medical Center Brackenridge
      • Bedford, Texas, United States, 76022
        • Texas Oncology
      • El Paso, Texas, United States, 79902
        • Texas Oncology, P.A. - El Paso; West
      • Houston, Texas, United States, 77024
        • Texas Oncology - Memorial City
      • Sherman, Texas, United States, 75090-0504
        • Texas Oncology, P.A. ;Sherman Cancer Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology Associates
    • Washington
      • Edmonds, Washington, United States, 98026
        • Puget Sound Cancer Centers
      • Seattle, Washington, United States, 98122
        • Swedish Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
  • Human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR) (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end organ function
  • Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer

Exclusion Criteria:

  • Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
  • Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor for advanced or metastatic breast cancer
  • History of intolerance to a taxane-containing therapy
  • History of clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Clinically significant history of liver disease
  • Active autoimmune disease or active inflammatory disease
  • Immunocompromised status due to current known active infection with human immunodeficiency virus (HIV) or due to the use of immunosuppressive therapies for other conditions
  • Need for current chronic corticosteroid therapy
  • Pregnant, lactating, or breastfeeding women
  • Current severe, uncontrolled systemic disease
  • Known untreated or active central nervous system (CNS) metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Paclitaxel, GDC-0941
Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle.
Drug: GDC-0941
GDC-0941 will be administered QD orally for 5 consecutive days each week.
Drug: Paclitaxel
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Placebo Comparator: B: Paclitaxel, Placebo
Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m^2 IV weekly for 3 out of 4 weeks in every 28-day cycle.
Drug: Paclitaxel
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Drug: Placebo
Placebo matching to GDC-0941

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Time Frame: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
From the time of randomization until disease progression or death from any cause (up to approximately 3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events
Time Frame: From randomization up to approximately 3 years
From randomization up to approximately 3 years
Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1
Time Frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Percentage of Participants Acheiving Clinical Benefit (Partial Response, Complete Response or Stable Disease Lasting for at Least 6 Months) Assessed as per Modified RECIST v1.1
Time Frame: From randomization until disease progression (up to approximately 3 years)
From randomization until disease progression (up to approximately 3 years)
Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1
Time Frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Population Pharmacokinetics (PK) for GDC-0941
Time Frame: Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
Population PK for Paclitaxel
Time Frame: Day 1 of Cycle 1 (cycle length=28 days)
Day 1 of Cycle 1 (cycle length=28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2013

Primary Completion (Actual)

October 20, 2015

Study Completion (Actual)

December 10, 2015

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO28509
  • 2012-003262-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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