A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.
Who is this study for? Adult patients with locally recurrent or metastatic triple negative breast cancer
What treatments are being studied? Capivasertib
Status: Active_not_recruiting
Location: See all (256) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• Histologically confirmed TNBC from most recently collected tumour tissue sample
• Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
• ECOG/WHO PS: 0-1
• Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease
• FFPE tumour sample from primary/recurrent cancer
Locations
United States
California
Research Site
Whittier
Research Site
Whittier
Florida
Research Site
Fort Myers
Research Site
Miami
Research Site
St. Petersburg
Research Site
Tampa
Illinois
Research Site
Chicago
Kansas
Research Site
Westwood
Maryland
Research Site
Silver Spring
Michigan
Research Site
Detroit
New York
Research Site
Nyack
Ohio
Research Site
Cincinnati
Research Site
Columbus
Pennsylvania
Research Site
Harrisburg
Research Site
Philadelphia
Research Site
Pittsburgh
Tennessee
Research Site
Nashville
Texas
Research Site
Austin
Research Site
Fort Worth
Research Site
Houston
Research Site
San Antonio
Virginia
Research Site
Fairfax
Other Locations
Argentina
Research Site
Buenos Aires
Research Site
Caba
Research Site
Caba
Research Site
Caba
Research Site
Caba
Research Site
Ciudad Autonomade Buenos Aires
Research Site
La Plata
Research Site
Mar Del Plata
Research Site
Rosario
Brazil
Research Site
Barretos
Research Site
Florianópolis
Research Site
Goiânia
Research Site
Londrina
Research Site
Natal
Research Site
Porto Alegre
Research Site
Porto Alegre
Research Site
Rio De Janeiro
Research Site
São José Do Rio Preto
Research Site
São Paulo
Research Site
São Paulo
Research Site
São Paulo
Canada
Research Site
Kitchener
Research Site
North York
Research Site
Toronto
Research Site
Victoria
China
Research Site
Beijing
Research Site
Beijing
Research Site
Changchun
Research Site
Changsha
Research Site
Changsha
Research Site
Chengdu
Research Site
Chengdu
Research Site
Foshan
Research Site
Guangzhou
Research Site
Guiyang
Research Site
Haikou
Research Site
Hangzhou
Research Site
Hangzhou
Research Site
Hangzhou
Research Site
Harbin
Research Site
Hefei
Research Site
Jinan
Research Site
Linyi
Research Site
Nanchang
Research Site
Nanjing
Research Site
Nanyang
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shenyang
Research Site
Ürümqi
Research Site
Wenzhou
Research Site
Wuhan
Research Site
Wuhan
Research Site
Xi'an
Research Site
Zhengzhou
Colombia
Research Site
Floridablanca
Research Site
Ibagué
Research Site
Medellín
Research Site
Montería
Research Site
Valledupar
France
Research Site
Brest
Research Site
Lyon
Research Site
Marseille
Research Site
Montpellier
Research Site
Nice
Research Site
Paris
Research Site
Saint-herblain
Research Site
Villejuif
Greece
Research Site
Athens
Research Site
Athens
Research Site
Athens
Research Site
Heraklion
Research Site
Thessaloniki
Hungary
Research Site
Budapest
Research Site
Budapest
Research Site
Budapest
Research Site
Győr
Research Site
Nyíregyháza
Research Site
Szekszárd
India
Research Site
Bangalore
Research Site
Bangalore
Research Site
Gūrgaon
Research Site
Kolkata
Research Site
Kolkata
Research Site
Mumbai
Research Site
Mysuru
Research Site
Nagpur
Research Site
Nagpur
Research Site
Nashik
Research Site
New Delhi
Research Site
New Delhi
Japan
Research Site
Bunkyō City
Research Site
Fukuoka
Research Site
Hidaka-shi
Research Site
Hiroshima
Research Site
Kagoshima
Research Site
Kitaadachi-gun
Research Site
Kōtoku
Research Site
Kumamoto
Research Site
Matsuyama
Research Site
Nagoya
Research Site
Niigata
Research Site
Osaka
Research Site
Osaka
Research Site
Ota-shi
Research Site
Sapporo
Research Site
Sendai
Research Site
Shinagawa-ku
Research Site
Shinjuku-ku
Research Site
Sunto-gun
Research Site
Takasaki-shi
Research Site
Tsu
Research Site
Tsukuba
Research Site
Yokohama
Malaysia
Research Site
Kuala Lumpur
Research Site
Kuala Lumpur
Research Site
Kuala Selangor
Research Site
Kuching
Mexico
Research Site
Aguascalientes
Research Site
Estado De México
Research Site
Guadalajara
Research Site
México
Research Site
Monterrey
Research Site
Tuxtla Gutiérrez
Research Site
Tuxtla Gutiérrez
Peru
Research Site
Arequipa
Research Site
Callao
Research Site
Lima
Research Site
Lima
Research Site
Lima
Research Site
Lima
Philippines
Research Site
Bacolod
Research Site
Baguio City
Research Site
Cagayan De Oro
Research Site
Cebu City
Research Site
Davao City
Research Site
Iloilo City
Research Site
Iloilo City
Research Site
Las Piñas
Research Site
Legaspi
Research Site
Manila
Research Site
Quezon City
Research Site
San Juan City
Poland
Research Site
Bydgoszcz
Research Site
Konin
Research Site
Poznan
Research Site
Racibórz
Research Site
Radom
Research Site
Tomaszów Mazowiecki
Research Site
Warsaw
Research Site
Wroclaw
Portugal
Research Site
Lisbon
Research Site
Lisbon
Research Site
Lisbon
Research Site
Porto
Republic of Korea
Research Site
Busan
Research Site
Cheonan-si
Research Site
Cheongju-si
Research Site
Daegu
Research Site
Goyang-si
Research Site
Incheon
Research Site
Seongnam-si
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Russian Federation
Research Site
Arkhangelsk
Research Site
Moscow
Research Site
Moscow
Research Site
Moscow
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Saint Petersburg
Research Site
Volgograd
Research Site
Yaroslavl
Saudi Arabia
Research Site
Dammam
Research Site
Jeddah
Research Site
Mecca
Research Site
Riyadh
Research Site
Riyadh
Research Site
Riyadh
Research Site
Riyadh
Slovakia
Research Site
Bratislava
South Africa
Research Site
Johannesburg
Research Site
Johannesburg
Research Site
Pretoria
Research Site
Pretoria
Spain
Research Site
Badalona
Research Site
Barcelona
Research Site
Barcelona
Research Site
Hospitalet Dellobregat
Research Site
Jaén
Research Site
Madrid
Research Site
Málaga
Research Site
Seville
Research Site
Valencia
Research Site
Zaragoza
Sweden
Research Site
Gothenburg
Research Site
Lund
Research Site
Stockholm
Taiwan
Research Site
Hsinchu
Research Site
Hualien City
Research Site
Kaohsiung City
Research Site
Kaohsiung City
Research Site
Tainan
Research Site
Tainan
Research Site
Taipei
Research Site
Taipei
Research Site
Taipei
Research Site
Taipei
Thailand
Research Site
Bangkok
Research Site
Bangkok
Research Site
Bangkok
Research Site
Bangkok
Research Site
Hat Yai
Research Site
Mueang
Turkey
Research Site
Ankara
Research Site
Ankara
Research Site
Istanbul
Research Site
Izmir
Research Site
Malatya
Research Site
Mersin
United Kingdom
Research Site
Edinburgh
Research Site
London
Research Site
London
Research Site
London
Research Site
Sheffield
Research Site
Surrey
Research Site
York
Viet Nam
Research Site
Hanoi
Research Site
Ho Chi Minh City
Research Site
Ho Chi Minh City
Time Frame
Start Date: 2019-06-25
Completion Date: 2026-03-16
Participants
Target number of participants: 923
Treatments
Experimental: Capivasertib + Paclitaxel
Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.~Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.
Placebo_comparator: Placebo + Paclitaxel
Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.~Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca