A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
NCT ID: NCT01572727
Last Updated: 2017-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
416 participants
INTERVENTIONAL
2012-08-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BKM120 and paclitaxel
Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel.
Paclitaxel
intravenous paclitaxel 80 mg/m2 per week given until progression
BKM120
Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
Placebo and paclitaxel
Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.
Paclitaxel
intravenous paclitaxel 80 mg/m2 per week given until progression
BKM120 matching placebo
Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.
Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
Interventions
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Paclitaxel
intravenous paclitaxel 80 mg/m2 per week given until progression
BKM120 matching placebo
Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.
Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
BKM120
Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)
* A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
* Adequate bone marrow and organ function
* Measurable or non-measurable disease
Exclusion Criteria
* Previous treatment with PI3K or AKT inhibitors
* Patient has symptomatic CNS metastases
* Concurrent malignancy or malignancy within 3 years of study enrollment
* Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug
* Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
* Active heart (cardiac) disease as defined in the protocol
* Known hypersensitivity or contraindications to use paclitaxel
* Pregnant or nursing (lactating) woman
* Certain scores on an anxiety and depression mood questionaire given at screening
* Other protocol defined criteria may apply
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States
Arizona Oncology Associates Dept of Oncology
Phoenix, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
California Cancer Care Marian Speciality
Greenbrae, California, United States
Rocky Mountain Cancer Centers RMCC Hale Pkwy
Greenwood Village, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute SC
Tampa, Florida, United States
Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)
Atlanta, Georgia, United States
Northwest Georgia Oncology Center NW Georgia Onc
Marietta, Georgia, United States
University of Kansas Cancer Center Univ Kansas 2
Kansas City, Kansas, United States
Norton Healthcare, Inc.
Louisville, Kentucky, United States
Washington University School of Medicine Regulatory
St Louis, Missouri, United States
University of Nebraska Medical Center Unv Nebraska Med Ctr (2)
Omaha, Nebraska, United States
University of New Mexico Cancer Research Center Dept of Univ New Mexico
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
Troy, New York, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center OUHSC 2
Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists Vancouver Loc
Portland, Oregon, United States
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
Dallas, Texas, United States
University of Texas Southwestern Medical Center Harry Hines
Dallas, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio
San Antonio, Texas, United States
Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA
Reston, Virginia, United States
Novartis Investigative Site
Sydney, New South Wales, Australia
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Geelong, Victoria, Australia
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Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
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Salzburg, , Austria
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Vienna, , Austria
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Charleroi, , Belgium
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Liège, , Belgium
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Ottignies, , Belgium
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Sint-Niklaas, , Belgium
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Wilrijk, , Belgium
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Fortaleza, Ceará, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Montreal, Quebec, Canada
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Brno, Czech Republic, Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Angers, , France
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Bordeaux, , France
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Créteil, , France
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La Roche-sur-Yon, , France
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Le Mans, , France
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Marseille, , France
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Nice, , France
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Saint-Herblain, , France
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Toulouse, , France
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Villejuif, , France
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Bonn, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Fulda, , Germany
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Mainz, , Germany
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München, , Germany
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Ravensburg, , Germany
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Ulm, , Germany
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Hong Kong SAR, , Hong Kong
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Budapest, , Hungary
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Debrecen, , Hungary
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Szolnok, , Hungary
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Cona, FE, Italy
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Genova, GE, Italy
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Monza, MB, Italy
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Messina, ME, Italy
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Milan, MI, Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Sapporo, Hokkaido, Japan
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Isehara, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Suita, Osaka, Japan
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Koto, Tokyo, Japan
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Breda, Netherlands, Netherlands
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Rotterdam, , Netherlands
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Saint Petersburg, Russia, Russia
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Saint Petersburg, , Russia
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Singapore, Singapore, Singapore
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Johannesburg, , South Africa
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Córdoba, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Zaragoza, Zaragoza, Spain
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Taipei, Taiwan, Taiwan
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Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan
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New Taipei City, , Taiwan
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Maidstone, Kent, United Kingdom
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Glasgow - Scotland, , United Kingdom
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London, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
Countries
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Other Identifiers
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2011-005932-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBKM120F2202
Identifier Type: -
Identifier Source: org_study_id
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