Clinical trial NCT01740336: A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer
Official title: A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
timeFrame: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: From randomization up to approximately 3 years
measure: Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1
timeFrame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
measure: 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
timeFrame: From randomization until disease progression (up to approximately 3 years)
measure: Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1
timeFrame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
measure: Population Pharmacokinetics (PK) for GDC-0941
timeFrame: Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
measure: Population PK for Paclitaxel
timeFrame: Day 1 of Cycle 1 (cycle length=28 days)
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Arizona Oncology Associates, PC - NAHOA
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Encinitas
country: United States
facility: California Cancer Associates for Research & Excellence, Inc.
state: California
city: Hayward
country: United States
facility: Kaiser Permanente - Hayward
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Medical Center - Roseville
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco (2238 Geary)
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: San Jose
country: United States
facility: Kaiser Permanente - San Jose
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente - South San Francisco
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Hartford
country: United States
facility: Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Orange Park
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology - Oncology Associates of Treasure Coast
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology-Hematology; Associates, Ltd.
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center
state: Kansas
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Metairie
country: United States
facility: Metairie Oncologist, LLC
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Brookline
country: United States
facility: Beth Israel Deaconess Med Ctr
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Billings
country: United States
facility: Billings Clinic Cancer Center-CCD PRIME
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists; Oncology Hematology West, PC
state: Nebraska
city: Lake Success
country: United States
facility: ProHEALTH Care Associates LLP
state: New York
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital; Aultman Hospital Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Oncology Institute
state: Ohio
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Hematology and Oncology Associates of Sc
state: South Carolina
city: Austin
country: United States
facility: Shivers Cancer Center at University Medical Center Brackenridge
state: Texas
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: El Paso
country: United States
facility: Texas Oncology, P.A. - El Paso; West
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Memorial City
state: Texas
city: Sherman
country: United States
facility: Texas Oncology, P.A. ;Sherman Cancer Center
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Winchester
country: United States
facility: Shenandoah Oncology Associates
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital;North Coast Cancer Institute
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Haematology & Oncology Clinic
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Mackay
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Bendigo
country: Australia
facility: Bendigo Hospital; Oncology
state: Victoria
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Grou
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital; Medical Oncology
state: Western Australia
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Wien
country: Austria
facility: Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec a.s.
city: Pardubice
country: Czechia
facility: Multiscan s.r.o.
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Badalona
country: Spain
facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Madrid
country: Spain
facility: Hospital General Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Barts Hospital
city: Manchester
country: United Kingdom
facility: The Christie
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.