A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer
A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
2 other identifiers
interventional
183
7 countries
84
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Feb 2013
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedStudy Start
First participant enrolled
February 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2015
CompletedApril 24, 2017
April 1, 2017
2.7 years
November 30, 2012
April 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
Secondary Outcomes (6)
Percentage of Participants With Adverse Events
From randomization up to approximately 3 years
Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1
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
From randomization until disease progression (up to approximately 3 years)
Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1
From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Population Pharmacokinetics (PK) for GDC-0941
Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
- +1 more secondary outcomes
Study Arms (2)
A: Paclitaxel, GDC-0941
EXPERIMENTALParticipants 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.
B: Paclitaxel, Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
GDC-0941 will be administered QD orally for 5 consecutive days each week.
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (97)
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336, United States
Pacific Cancer Medical Center
Anaheim, California, 92801, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, 92008, United States
Kaiser Permanente - Hayward
Hayward, California, 94545, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, 95661, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
Kaiser Permanente - San Francisco (2238 Geary)
San Francisco, California, 94115, United States
University of California at San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente - San Jose
San Jose, California, 95119, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente - South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research
Hartford, Connecticut, 06102-5037, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Cancer Specialists of North Florida
Orange Park, Florida, 32073, United States
Hematology - Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, 60435, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center
Topeka, Kansas, 66606, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70808, United States
Metairie Oncologist, LLC
Metairie, Louisiana, 70006, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med Ctr
Brookline, Massachusetts, 02445, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Billings Clinic Cancer Center-CCD PRIME
Billings, Missouri, Montana, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC
Omaha, Nebraska, 68130, United States
ProHEALTH Care Associates LLP
Lake Success, New York, 11042, United States
Summa Health System
Akron, Ohio, 44304, United States
Aultman Hospital; Aultman Hospital Cancer Center
Canton, Ohio, 44710, United States
TriHealth Oncology Institute
Cincinnati, Ohio, 45247, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Hematology and Oncology Associates of Sc
Greenville, South Carolina, 29615, United States
Shivers Cancer Center at University Medical Center Brackenridge
Austin, Texas, 78701, United States
Texas Oncology
Bedford, Texas, 76022, United States
Texas Oncology, P.A. - El Paso; West
El Paso, Texas, 79902, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Texas Oncology, P.A. ;Sherman Cancer Center
Sherman, Texas, 75090-0504, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Shenandoah Oncology Associates
Winchester, Virginia, 22601, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
Swedish Health Services
Seattle, Washington, 98122, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Port Macquarie Base Hospital;North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
Sydney Haematology & Oncology Clinic
Wahroonga, New South Wales, 2076, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Border Medical Oncology
Wodonga, New South Wales, 3690, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Adult Hospital
Mackay, Queensland, 4740, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, 5037, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Bendigo Hospital; Oncology
Bendigo, Victoria, 3550, Australia
Peninsula and South Eastern Haematology and Oncology Grou
Frankston, Victoria, 3199, Australia
Royal Perth Hospital; Medical Oncology
Perth, Western Australia, 6000, Australia
Lkh-Univ. Klinikum Graz
Graz, 8036, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel
Vienna, 1130, Austria
Klinikum Wels-Grieskirchen
Wels, 4600, Austria
Institut Jules Bordet
Brussels, 1000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU Ambroise Paré
Mons, 7000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Fakultni nemocnice Brno
Brno, 613 00, Czechia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Krajska nemocnice Liberec a.s.
Liberec, 460 63, Czechia
Multiscan s.r.o.
Pardubice, 532 03, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Nemocnice Na Bulovce
Prague, 180 01, Czechia
Thomayerova nemocnice
Praha 4 - Krc, 140 59, Czechia
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital General Univ. Gregorio Maranon
Madrid, 28009, Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050, Spain
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Barts Hospital
London, E1 2EF, United Kingdom
The Christie
Manchester, M20 4BX, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Vuylsteke P, Huizing M, Petrakova K, Roylance R, Laing R, Chan S, Abell F, Gendreau S, Rooney I, Apt D, Zhou J, Singel S, Fehrenbacher L. Pictilisib PI3Kinase inhibitor (a phosphatidylinositol 3-kinase [PI3K] inhibitor) plus paclitaxel for the treatment of hormone receptor-positive, HER2-negative, locally recurrent, or metastatic breast cancer: interim analysis of the multicentre, placebo-controlled, phase II randomised PEGGY study. Ann Oncol. 2016 Nov;27(11):2059-2066. doi: 10.1093/annonc/mdw320. Epub 2016 Aug 29.
PMID: 27573562DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
December 4, 2012
Study Start
February 6, 2013
Primary Completion
October 20, 2015
Study Completion
December 10, 2015
Last Updated
April 24, 2017
Record last verified: 2017-04