Breast Cancer Clinical Trial
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
| Verified date | April 2017 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 183 |
| Est. completion date | December 10, 2015 |
| Est. primary completion date | October 20, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Bendigo Hospital; Oncology | Bendigo | Victoria |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | Peninsula and South Eastern Haematology and Oncology Grou | Frankston | Victoria |
| Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
| Australia | Royal Hobart Hospital | Hobart | Tasmania |
| Australia | Ashford Cancer Center Research | Kurralta Park | South Australia |
| Australia | Mater Adult Hospital | Mackay | Queensland |
| Australia | Royal Perth Hospital; Medical Oncology | Perth | Western Australia |
| Australia | Port Macquarie Base Hospital;North Coast Cancer Institute | Port Macquarie | New South Wales |
| Australia | Sydney Haematology & Oncology Clinic | Wahroonga | New South Wales |
| Australia | Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales |
| Australia | Border Medical Oncology | Wodonga | New South Wales |
| Austria | Lkh-Univ. Klinikum Graz | Graz | |
| Austria | LKH - Universitätsklinikum der PMU Salzburg | Salzburg | |
| Austria | Klinikum Wels-Grieskirchen | Wels | |
| Austria | Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel | Wien | |
| Belgium | Institut Jules Bordet | Brussels | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | UZ Leuven Gasthuisberg | Leuven | |
| Belgium | CHU Ambroise Paré | Mons | |
| Belgium | Clinique Ste-Elisabeth | Namur | |
| Belgium | Sint Augustinus Wilrijk | Wilrijk | |
| Czechia | Fakultni nemocnice Brno | Brno | |
| Czechia | Masarykuv onkologicky ustav | Brno | |
| Czechia | Krajska nemocnice Liberec a.s. | Liberec | |
| Czechia | Multiscan s.r.o. | Pardubice | |
| Czechia | Nemocnice Na Bulovce | Prague | |
| Czechia | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
| Czechia | Thomayerova nemocnice | Praha 4 - Krc | |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Spain | Institut Catala d´Oncologia Hospital Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | |
| Spain | Complejo Hospitalario de Jaen | Jaen | |
| Spain | Hospital General Univ. Gregorio Maranon | Madrid | |
| Spain | START Madrid. Centro Integral Oncologico Clara Campal; CIOCC | Madrid | |
| United Kingdom | Royal Sussex County Hospital | Brighton | |
| United Kingdom | Royal Surrey County Hospital | Guildford | |
| United Kingdom | Leicester Royal Infirmary | Leicester | |
| United Kingdom | Barts Hospital | London | |
| United Kingdom | The Christie | Manchester | |
| 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 | Royal Cornwall Hospital | Truro | |
| United Kingdom | New Cross Hospital | Wolverhampton | |
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | Summa Health System | Akron | Ohio |
| United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
| United States | Pacific Cancer Medical Center | Anaheim | California |
| United States | Maine Research Associates | Auburn | Maine |
| United States | Shivers Cancer Center at University Medical Center Brackenridge | Austin | Texas |
| United States | Hematology Oncology Clinic | Baton Rouge | Louisiana |
| United States | Texas Oncology | Bedford | Texas |
| United States | Billings Clinic Cancer Center-CCD PRIME | Billings | Missouri |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Beth Israel Deaconess Med Ctr | Brookline | Massachusetts |
| United States | Aultman Hospital; Aultman Hospital Cancer Center | Canton | Ohio |
| United States | TriHealth Oncology Institute | Cincinnati | Ohio |
| United States | Clinical Research of South Florida | Coral Gables | Florida |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Puget Sound Cancer Centers | Edmonds | Washington |
| United States | Texas Oncology, P.A. - El Paso; West | El Paso | Texas |
| United States | California Cancer Associates for Research & Excellence, Inc. | Encinitas | California |
| United States | Hematology and Oncology Associates of Sc | Greenville | South Carolina |
| United States | Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research | Hartford | Connecticut |
| United States | Kaiser Permanente - Hayward | Hayward | California |
| United States | Texas Oncology - Memorial City | Houston | Texas |
| United States | Joliet Oncology-Hematology; Associates, Ltd. | Joliet | Illinois |
| United States | ProHEALTH Care Associates LLP | Lake Success | New York |
| United States | Metairie Oncologist, LLC | Metairie | Louisiana |
| United States | Kaiser Permanente - Oakland | Oakland | California |
| United States | Northern Utah Associates | Ogden | Utah |
| United States | Nebraska Cancer Specialists; Oncology Hematology West, PC | Omaha | Nebraska |
| United States | Cancer Specialists of North Florida | Orange Park | Florida |
| United States | Oncology Specialists, S.C. | Park Ridge | Illinois |
| United States | Illinois Cancer Care | Peoria | Illinois |
| United States | Bay Area Cancer Research Group, LLC | Pleasant Hill | California |
| United States | Hematology - Oncology Associates of Treasure Coast | Port Saint Lucie | Florida |
| United States | Kaiser Permanente Medical Center - Roseville | Roseville | California |
| United States | Kaiser Permanente Sacramento Medical Center | Sacramento | California |
| United States | Kaiser Permanente - San Francisco (2238 Geary) | San Francisco | California |
| United States | University of California at San Francisco | San Francisco | California |
| United States | Kaiser Permanente - San Jose | San Jose | California |
| United States | Kaiser Permanente - Santa Clara | Santa Clara | California |
| United States | Swedish Health Services | Seattle | Washington |
| United States | Arizona Oncology Associates, PC - NAHOA | Sedona | Arizona |
| United States | Texas Oncology, P.A. ;Sherman Cancer Center | Sherman | Texas |
| United States | Kaiser Permanente - South San Francisco | South San Francisco | California |
| United States | Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center | Topeka | Kansas |
| United States | Kaiser Permanente - Vallejo | Vallejo | California |
| United States | Kaiser Permanente - Walnut Creek | Walnut Creek | California |
| United States | Shenandoah Oncology Associates | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Australia, Austria, Belgium, Czechia, Korea, Republic of, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Percentage of Participants With Adverse Events | From randomization up to approximately 3 years | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | Population Pharmacokinetics (PK) for GDC-0941 | Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days) | ||
| Secondary | Population PK for Paclitaxel | Day 1 of Cycle 1 (cycle length=28 days) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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