A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer
- Registration Number
- NCT01740336
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 183
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B: Paclitaxel, Placebo 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. A: Paclitaxel, GDC-0941 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. A: Paclitaxel, GDC-0941 Paclitaxel 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. B: Paclitaxel, Placebo Paclitaxel 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Population PK for Paclitaxel Day 1 of Cycle 1 (cycle length=28 days) 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) 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) Population Pharmacokinetics (PK) for GDC-0941 Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
Trial Locations
- Locations (97)
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research
🇺🇸Hartford, Connecticut, United States
Oncology Specialists, S.C.
🇺🇸Park Ridge, Illinois, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Puget Sound Cancer Centers
🇺🇸Edmonds, Washington, United States
TriHealth Oncology Institute
🇺🇸Cincinnati, Ohio, United States
Clinique Ste-Elisabeth
🇧🇪Namur, Belgium
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Kaiser Permanente - San Francisco (2238 Geary)
🇺🇸San Francisco, California, United States
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel
🇦🇹Wien, Austria
Arizona Oncology Associates, PC - NAHOA
🇺🇸Sedona, Arizona, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Border Medical Oncology
🇦🇺Wodonga, New South Wales, Australia
Shivers Cancer Center at University Medical Center Brackenridge
🇺🇸Austin, Texas, United States
Aultman Hospital; Aultman Hospital Cancer Center
🇺🇸Canton, Ohio, United States
Cancer Specialists of North Florida
🇺🇸Orange Park, Florida, United States
Texas Oncology
🇺🇸Bedford, Texas, United States
Mater Adult Hospital
🇦🇺Mackay, Queensland, Australia
Bendigo Hospital; Oncology
🇦🇺Bendigo, Victoria, Australia
Shenandoah Oncology Associates
🇺🇸Winchester, Virginia, United States
Kaiser Permanente - South San Francisco
🇺🇸South San Francisco, California, United States
ProHEALTH Care Associates LLP
🇺🇸Lake Success, New York, United States
Texas Oncology, P.A. - El Paso; West
🇺🇸El Paso, Texas, United States
UZ Antwerpen
🇧🇪Edegem, Belgium
Swedish Health Services
🇺🇸Seattle, Washington, United States
Institut Catala d Oncologia Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Texas Oncology - Memorial City
🇺🇸Houston, Texas, United States
Hematology and Oncology Associates of Sc
🇺🇸Greenville, South Carolina, United States
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Bay Area Cancer Research Group, LLC
🇺🇸Pleasant Hill, California, United States
Ashford Cancer Center Research
🇦🇺Kurralta Park, South Australia, Australia
Port Macquarie Base Hospital;North Coast Cancer Institute
🇦🇺Port Macquarie, New South Wales, Australia
Krajska nemocnice Liberec a.s.
🇨🇿Liberec, Czechia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Peninsula and South Eastern Haematology and Oncology Grou
🇦🇺Frankston, Victoria, Australia
Lkh-Univ. Klinikum Graz
🇦🇹Graz, Austria
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Nemocnice Na Bulovce
🇨🇿Prague, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
The Christie
🇬🇧Manchester, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals City Campus
🇬🇧Nottingham, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke on Trent, United Kingdom
Northern Utah Associates
🇺🇸Ogden, Utah, United States
Thomayerova nemocnice
🇨🇿Praha 4 - Krc, Czechia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Sydney Haematology & Oncology Clinic
🇦🇺Wahroonga, New South Wales, Australia
California Cancer Associates for Research & Excellence, Inc.
🇺🇸Encinitas, California, United States
Kaiser Permanente - Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente - San Jose
🇺🇸San Jose, California, United States
Kaiser Permanente - Santa Clara
🇺🇸Santa Clara, California, United States
Kaiser Permanente - Vallejo
🇺🇸Vallejo, California, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
Joliet Oncology-Hematology; Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Billings Clinic Cancer Center-CCD PRIME
🇺🇸Billings, Missouri, United States
Texas Oncology, P.A. ;Sherman Cancer Center
🇺🇸Sherman, Texas, United States
Multiscan s.r.o.
🇨🇿Pardubice, Czechia
Royal Perth Hospital; Medical Oncology
🇦🇺Perth, Western Australia, Australia
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital General Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Complejo Hospitalario de Jaen
🇪🇸Jaen, Spain
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Kaiser Permanente - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente Sacramento Medical Center
🇺🇸Sacramento, California, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC
🇺🇸Omaha, Nebraska, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Kaiser Permanente - Walnut Creek
🇺🇸Walnut Creek, California, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Hematology - Oncology Associates of Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Calvary Mater Newcastle; Medical Oncology
🇦🇺Waratah, New South Wales, Australia
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Metairie Oncologist, LLC
🇺🇸Metairie, Louisiana, United States
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Maine Research Associates
🇺🇸Auburn, Maine, United States
Beth Israel Deaconess Med Ctr
🇺🇸Brookline, Massachusetts, United States
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
🇪🇸Madrid, Spain
Barts Hospital
🇬🇧London, United Kingdom
LKH - Universitätsklinikum der PMU Salzburg
🇦🇹Salzburg, Austria
Sint Augustinus Wilrijk
🇧🇪Wilrijk, Belgium
CHU Ambroise Paré
🇧🇪Mons, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium