Spots Global Cancer Trial Database for Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
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Trial Identification
Brief Title: Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
Official Title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation
Study ID: NCT04251533
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
Detailed Description: The recruitment of Part A was halted on 11-Nov-2022 due to slow recruitment. Since Part B1 did not meet its primary objective for confirmed overall response rate the Part B2 will not be initiated and the recruitment was halted for the entire study
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Of California Los Angeles Santa Monica Location, Los Angeles, California, United States
Hematology and Oncology Clinic SC, Baton Rouge, Louisiana, United States
Mayo Clinic Rochester Mayo - Roch., Rochester, Minnesota, United States
Park Nicollet Institute Dept Onc, Saint Louis Park, Minnesota, United States
SCRI Oncology Partners Tennessee Oncology (3), Nashville, Tennessee, United States
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Rosario, Santa Fe, Argentina
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Nedlands, Western Australia, Australia
Novartis Investigative Site, Innsbruck, Tyrol, Austria
Novartis Investigative Site, Leoben, , Austria
Novartis Investigative Site, Barretos, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Hefei, Anhui, China
Novartis Investigative Site, Shijiazhuang, Hebei, China
Novartis Investigative Site, Changsha, Hunan, China
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Chang Chun, Jilin, China
Novartis Investigative Site, Shengyang, Liaoning, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Dalian, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Shenyang, , China
Novartis Investigative Site, Tianjin, , China
Novartis Investigative Site, Bogota, , Colombia
Novartis Investigative Site, Zagreb, , Croatia
Novartis Investigative Site, Saint-Cloud, Hauts De Seine, France
Novartis Investigative Site, Angers Cedex 02, , France
Novartis Investigative Site, Saint-Herblain Cédex, , France
Novartis Investigative Site, Villejuif, , France
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Faridabad, Haryana, India
Novartis Investigative Site, Mumbai, Maharashtra, India
Novartis Investigative Site, Vellore, Tamil Nadu, India
Novartis Investigative Site, Hyderabad, Telangana, India
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Meldola, FC, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Napoli, , Italy
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Petaling Jaya, Selangor, Malaysia
Novartis Investigative Site, Kuala Lumpur, , Malaysia
Novartis Investigative Site, Monterrey, Nuevo Leon, Mexico
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Trujillo, La Libertad, Peru
Novartis Investigative Site, Gdynia, , Poland
Novartis Investigative Site, Opole, , Poland
Novartis Investigative Site, Poznan, , Poland
Novartis Investigative Site, Arkhangelsk, , Russian Federation
Novartis Investigative Site, Chelyabinsk, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Pushkin Saint Petersburg, , Russian Federation
Novartis Investigative Site, Bratislava, Slovak Republic, Slovakia
Novartis Investigative Site, Bratislava, , Slovakia
Novartis Investigative Site, Kosice, , Slovakia
Novartis Investigative Site, Ljubljana, , Slovenia
Novartis Investigative Site, Port Elizabeth, Western Cape, South Africa
Novartis Investigative Site, Johannesburg, , South Africa
Novartis Investigative Site, Alicante, Comunidad Valenciana, Spain
Novartis Investigative Site, Badajoz, Extremadura, Spain
Novartis Investigative Site, Palma De Mallorca, Islas Baleares, Spain
Novartis Investigative Site, Lausanne, , Switzerland
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Nottingham, , United Kingdom
Novartis Investigative Site, Oxford, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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