Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

PHASE2CompletedINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

August 29, 2017

Primary Completion Date

June 14, 2021

Study Completion Date

November 12, 2024

Conditions
Breast Cancer
Interventions
DRUG

Alpelisib

300 mg of alpelisib film-coated tablets administered orally once daily

DRUG

Fulvestrant

500 mg of fulvestrant via intramuscular injection administered on Days 1, 15 on Cycle 1 and Day 1 at each cycle thereafter. Cycle=28 days

DRUG

Letrozole

2.5 mg of letrozole film-coated tablets administered orally once daily

DRUG

Goserelin

3.6 mg of goserelin via injectable subcutaneous implant administered every 28 days. Only for men in Cohort B and premenopausal women.

DRUG

Leuprolide

7.5 mg of leuprolide via injectable intramuscular depot administered every 28 days. Only for men in cohort B and premenopausal women.

Trial Locations (94)

3000

Novartis Investigative Site, Leuven

4000

Novartis Investigative Site, Liège

5000

Novartis Investigative Site, Odense C

5300

Novartis Investigative Site, La Rioja

10002

Novartis Investigative Site, Taipei

10065

Memorial Sloane Ketterin Cancer Ctr, New York

12002

Novartis Investigative Site, Castellon

14021

Novartis Investigative Site, Caen

14169

Novartis Investigative Site, Berlin

16132

Novartis Investigative Site, Genova

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

21202

Mercy Medical Center, Baltimore

21204

Greater Baltimore Med Center Cancer Center, Baltimore

23502

Virginia Oncology Associates, Norfolk

24127

Novartis Investigative Site, Bergamo

28041

Novartis Investigative Site, Madrid

31059

Novartis Investigative Site, Toulouse

32804

Advent Health Cancer Institute, Orlando

33076

Novartis Investigative Site, Bordeaux

34298

Novartis Investigative Site, Montpellier

37007

Novartis Investigative Site, Salamanca

40138

Novartis Investigative Site, Bologna

40202

University of Louisville James Graham Brown Cancer Center, Louisville

41013

Novartis Investigative Site, Seville

44106

Uni Hosp of Cleveland Cancer Center, Cleveland

44805

Novartis Investigative Site, Saint-Herblain

45136

Novartis Investigative Site, Essen

45640

Novartis Investigative Site, Jalisco

48202

Josephine Ford Cancer Center, Detroit

59020

Novartis Investigative Site, Lille

59102

St Vincent Frontier Cancer Center, Billings

60126

Novartis Investigative Site, Ancona

66205

University of Kansas Cancer Center, Kansas City

67000

Novartis Investigative Site, Strasbourg

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

70403

Novartis Investigative Site, Tainan City

75246

Texas Oncology, Dallas

78229

Cancer Care Centers of South Texas HOAST, San Antonio

UT Health San Antonio, San Antonio

80131

Novartis Investigative Site, Napoli

85054

Mayo Clinic Arizona, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

86150

Novartis Investigative Site, Augsburg

87106

New Mexico Cancer Care Alliance, Albuquerque

89081

Novartis Investigative Site, Ulm

90211

Beverly Hills Cancer Center, Beverly Hills

91054

Novartis Investigative Site, Erlangen

92120

Kaiser Permanent Southern Californi, San Diego

92210

Novartis Investigative Site, Saint-Cloud

92660

University of Calif Irvine Med Cntr, Irvine

92807

Kaiser Permanente Medical Group, Anaheim

94115

UCSF, San Francisco

98405

Northwest Medical Specialists, Tacoma

103616

Novartis Investigative Site, Taipei

110085

Novartis Investigative Site, Delhi

168583

Novartis Investigative Site, Singapore

217562

Novartis Investigative Site, Singapore

4810469

Novartis Investigative Site, Temuco

4941492

Novartis Investigative Site, Petah Tikva

5265601

Novartis Investigative Site, Ramat Gan

6423906

Novartis Investigative Site, Tel Aviv

7500921

Novartis Investigative Site, Santiago

7661041

Novartis Investigative Site, Rehovot

8420383

Novartis Investigative Site, Santiago

06511

Yale University Yale Cancer Center, New Haven

02114

Massachusetts General Hospital, Boston

01805

Lahey Clinic, Burlington

C1118AAT

Novartis Investigative Site, CABA

C1125ABD

Novartis Investigative Site, CABA

C1426ANZ

Novartis Investigative Site, CABA

S2000DSV

Novartis Investigative Site, Rosario

S200KZE

Novartis Investigative Site, Rosario

V5Z 4E6

Novartis Investigative Site, Vancouver

B3H 2Y9

Novartis Investigative Site, Halifax

N2G 1G3

Novartis Investigative Site, Kitchener

M5B 1N9

Novartis Investigative Site, Toronto

DK-7100

Novartis Investigative Site, Vejle

06189

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

00168

Novartis Investigative Site, Roma

540-0006

Novartis Investigative Site, Osaka

6229 HX

Novartis Investigative Site, Maastricht

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

EH4 2XU

Novartis Investigative Site, Edinburgh

SM2 5PT

Novartis Investigative Site, Sutton

LE1 5WW

Novartis Investigative Site, Leicester

SW3 6JJ

Novartis Investigative Site, London

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY