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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

June 8, 2020

Primary Completion Date

May 31, 2023

Study Completion Date

January 13, 2026

Conditions
Triple Negative Breast Neoplasms
Interventions
DRUG

alpelisib

300 mg orally, once per day (QD), tablets

DRUG

placebo

300 mg orally, once per day (QD), tablets

DRUG

nab-paclitaxel

100 mg/m\^2 IV infusion, once per day (QD)

Trial Locations (78)

1000

Novartis Investigative Site, Ljubljana

1011

Novartis Investigative Site, Lausanne

1134

Novartis Investigative Site, Budapest

2196

Novartis Investigative Site, Johannesburg

3000

Novartis Investigative Site, Melbourne

4004

Novartis Investigative Site, Plovdiv

6009

Novartis Investigative Site, Nedlands

6020

Novartis Investigative Site, Innsbruck

6045

Novartis Investigative Site, Port Elizabeth

10000

Novartis Investigative Site, Zagreb

10002

Novartis Investigative Site, Taipei

10449

Novartis Investigative Site, Taipei

13011

Novartis Investigative Site, Trujillo

34098

Novartis Investigative Site, Istanbul

34722

Novartis Investigative Site, Istanbul

37203

SCRI Oncology Partners, Nashville

44805

Novartis Investigative Site, Saint-Herblain

45136

Novartis Investigative Site, Essen

46050

Novartis Investigative Site, Petaling Jaya

47014

Novartis Investigative Site, Meldola

49055

Novartis Investigative Site, Angers

55416

Park Nicollet Institute, Saint Louis Park

55905

Mayo Clinic Rochester, Rochester

59100

Novartis Investigative Site, Kuala Lumpur

64460

Novartis Investigative Site, Monterrey

70809

Hematology and Oncology Clinic, Baton Rouge

80131

Novartis Investigative Site, Napoli

83310

Novartis Investigative Site, Bratislava

90095

University of California LA, Los Angeles

92210

Novartis Investigative Site, Saint-Cloud

94800

Novartis Investigative Site, Villejuif

110011

Novartis Investigative Site, Shenyang

110042

Novartis Investigative Site, Shengyang

110221

Novartis Investigative Site, Bogotá

116000

Novartis Investigative Site, Dalian

117997

Novartis Investigative Site, Moscow

123056

Novartis Investigative Site, Moscow

130021

Novartis Investigative Site, Changchun

163045

Novartis Investigative Site, Arkhangelsk

196603

Novartis Investigative Site, Saint Petersburg

200025

Novartis Investigative Site, Shanghai

210029

Novartis Investigative Site, Nanjing

230001

Novartis Investigative Site, Hefei

300480

Novartis Investigative Site, Tianjin

310016

Novartis Investigative Site, Hangzhou

330009

Novartis Investigative Site, Nanchang

400056

Novartis Investigative Site, Mumbai

410013

Novartis Investigative Site, Changsha

454048

Novartis Investigative Site, Chelyabinsk

500034

Novartis Investigative Site, Hyderabad

610041

Novartis Investigative Site, Chengdu

6423906

Novartis Investigative Site, Tel Aviv

S2000KZE

Novartis Investigative Site, Rosario

C1113AAE

Novartis Investigative Site, CABA

A 8700

Novartis Investigative Site, Leoben

14784 400

Novartis Investigative Site, Barretos

01317-002

Novartis Investigative Site, São Paulo

04014-002

Novartis Investigative Site, São Paulo

050011

Novartis Investigative Site, Shijiazhuang

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

121 001

Novartis Investigative Site, Faridabad

632 004

Novartis Investigative Site, Vellore

00128

Novartis Investigative Site, Roma

NO-0407

Novartis Investigative Site, Oslo

81 519

Novartis Investigative Site, Gdynia

45-061

Novartis Investigative Site, Opole

61 485

Novartis Investigative Site, Poznan

812 50

Novartis Investigative Site, Bratislava

041 91

Novartis Investigative Site, Košice

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

07120

Novartis Investigative Site, Palma

06080

Novartis Investigative Site, Badajoz

03010

Novartis Investigative Site, Alicante

NG5 1PB

Novartis Investigative Site, Nottingham

OX3 7LE

Novartis Investigative Site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY