Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

521

Participants

Timeline

Start Date

November 18, 2019

Primary Completion Date

January 16, 2023

Study Completion Date

December 27, 2023

Conditions
Breast Cancer
Interventions
BIOLOGICAL

nivolumab

Specified Dose on Specified days

DRUG

paclitaxel (PTX)

Specified dose on Specified days

OTHER

nivolumab placebo

Specified dose on Specified days

DRUG

anthracycline

Specified dose on Specified days

DRUG

cyclophosphamide

Specified dose on Specified days

DRUG

Endocrine Therapy

Variable endocrine therapy of investigators choice

PROCEDURE

Surgery

Surgery for breast cancer

Trial Locations (240)

0

Local Institution - 0013, Buenos Aires

Local Institution - 0016, Santiago

Local Institution - 0203, Colombia

Local Institution - 0093, Santiago de Cali

Local Institution - 0115, Hong Kong

807

Local Institution - 0301, Kaohsiung City

1011

Local Institution - 0186, Lausanne

1090

Local Institution - 0046, Vienna

Local Institution - 0047, Vienna

Local Institution - 0187, Brussels

1430

Local Institution - 0011, Caba

1431

Local Institution - 0012, Ciudad Autonoma Beunos Aires

1900

Local Institution - 0015, La Plata

2060

Local Institution - 0071, North Sydney

2100

Local Institution - 0164, København Ø

2444

Local Institution - 0069, Port Macquarie

2650

Local Institution - 0037, Edegem

2730

Local Institution - 0165, Herlev

3000

Local Institution - 0070, Melbourne

3168

Local Institution - 0066, Clayton

Local Institution - 0142, Clayton

3600

Local Institution - 0185, Thun

4000

Local Institution - 0031, Liège

4029

Local Institution - 0072, Herston

4031

Local Institution - 0184, Basel

4200

Local Institution - 0209, Porto

4700

Local Institution - 0166, Næstved

5020

Local Institution - 0048, Salzburg

5112

Local Institution - 0067, Elizabeth Vale

5800

Local Institution - 0303, Río Cuarto

6000

Local Institution - 0030, Charleroi

6020

Local Institution - 0042, Innsbruck

8036

Local Institution - 0045, Graz

8200

Local Institution - 0167, Aarhus N

9000

Local Institution - 0032, Ghent

10449

Local Institution - 0305, Taipei

10461

Local Institution - 0041, The Bronx

11217

Local Institution - 0297, Taipei

13125

Local Institution - 0083, Berlin

13620

Local Institution - 0325, Seongnam

14080

Local Institution - 0154, Mexico City

15706

Local Institution - 0174, Santiago de Compostela

18059

Local Institution - 0156, Rostock

20089

Local Institution - 0125, Rozzano (MI)

20141

Local Institution - 0207, Milan

20259

Local Institution - 0223, Hamburg

20817

Local Institution - 0146, Bethesda

22010

Local Institution - 0262, Tijuana

22031

Local Institution - 0224, Fairfax

22190

Local Institution - 0195, Plérin

22408

Local Institution - 0122, Fredericksburg

23230

Virginia Cancer Institute, Richmond

24050

Local Institution - 0280, Campeche

25030

Local Institution - 0004, Besançon

27100

Fondazione Irccs - Policlinico San Matteo, Pavia

27710

Duke Cancer Institute, Durham

28018

Local Institution - 0145, Colima

28040

Local Institution - 0173, Madrid

28050

Local Institution - 0176, Madrid

28204

Local Institution - 0283, Charlotte

29010

Local Institution - 0169, Málaga

29200

Local Institution - 0024, Brest

30342

Local Institution - 0107, Atlanta

30607

Local Institution - 0054, Athens

31000

Local Institution - 0091, Chihuahua City

31008

Local Institution - 0204, Pamplona

31904

Local Institution - 0056, Columbus

32256

Local Institution - 0150, Jacksonville

32308

Local Institution - 0120, Tallahassee

32504

Local Institution - 0149, Pensacola

33136

Local Institution - 0097, Miami

33500

Local Institution - 0068, North Ballarat

33521

Local Institution - 0160, Tampere

34298

Local Institution - 0152, Montpellier

34300

Local Institution - 0074, Istanbul

35128

Local Institution - 0155, Padua

36604

Local Institution - 0136, Mobile

37203

Local Institution - 0218, Nashville

41013

Local Institution - 0170, Seville

41061

Local Institution - 0111, Mönchengladbach

42551

Local Institution - 0157, Velbert

44109

Local Institution - 0053, Cleveland

44805

Local Institution - 0002, Saint-Herblain

45070

Local Institution - 0330, Zapopan

45147

Local Institution - 0081, Essen

46010

Local Institution - 0175, Valencia

46804

Local Institution - 0227, Fort Wayne

50051

Local Institution - 0240, Shjiazhuang

50937

Local Institution - 0080, Cologne

60590

Local Institution - 0158, Frankfurt

60611

Local Institution - 0221, Chicago

63011

Local Institution - 0162, Clermont-Ferrand

64132

HCA Midwest Division, Kansas City

64320

Local Institution - 0137, Monterrey

66113

Local Institution - 0079, Saarbrücken

66421

Local Institution - 0089, Homburg

67085

Local Institution - 0258, Strasbourg

68020

Local Institution - 0141, Oaxaca City

69000

Local Institution - 0153, Lyon

69126

Local Institution - 0087, Heidelberg

70457

Local Institution - 0298, Tainan City

71004

Local Institution - 0300, Tainan City

72000

Local Institution - 0216, Le Mans

75908

Local Institution - 0161, Paris

76104

Local Institution - 0121, Fort Worth

80131

Azienda Ospedaliero Universitaria Federico II di Napoli, Napoli

Local Institution - 0124, Napoli

80337

Local Institution - 0084, München

83056

Local Institution - 0228, Toulon

85796

Local Institution - 0335, Bydgoszcz

87131

Local Institution - 0181, Albuquerque

88100

Local Institution - 0191, Catanzaro

90603

Local Institution - 0051, Whittier

94800

Local Institution - 0003, Villejuif

94904

Local Institution - 0052, Greenbrae

97080

Local Institution - 0105, Würzburg

97125

Local Institution - 0212, Mérida

98109

Local Institution - 0274, Seattle

100021

Local Institution, Beijing

100044

Local Institution - 0215, Beijing

110042

Local Institution - 0252, Shenyang

110221

Local Institution - 0094, Bogotá

111123

Local Institution - 0285, Moskva

115478

Local Institution - 0119, Moscow

119228

Local Institution - 0078, Singapore

125367

Local Institution, Moscow

130012

Local Institution - 0255, Changchun

130021

Local Institution - 0247, Changchun

150001

Local Institution - 0248, Harbin

168583

Local Institution - 0076, Singapore

194107

Local Institution - 0306, Saint Petersburg

197758

Local Institution - 0284, Saint Petersburg

200032

Local Institution - 0127, Shanghai

200542

Local Institution - 0028, Craiova

230002

Local Institution - 0113, Montería

230031

Local Institution - 0239, Hefei

233004

Local Institution - 0235, Bengbu

250117

Local Institution - 0245, Jinan

264000

Local Institution - 0214, Yantai

266000

Local Institution - 0256, Qingdao

300060

Local Institution - 0254, Tianjin

308442

Local Institution - 0077, Singapore

310000

Local Institution - 0238, Hangzhou

310003

Local Institution - 0231, Hangzhou

310009

Local Institution - 0237, Hangzhou

350040

Local Institution, Krasnodar

354057

Local Institution, Sochi

390011

Local Institution, Ryazan

400016

Local Institution - 0319, Chongqing

400030

Local Institution - 0232, Chongqing

407280

Local Institution - 0027, Floreşti

430022

Local Institution - 0250, Wuhan

510060

Local Institution - 0267, Guangzhou

510080

Local Institution - 0241, Guangzhou

510515

Local Institution, Guangzhou

563000

Local Institution - 0312, Zunyi

610041

Local Institution - 0244, Chengdu

660004

Local Institution - 0271, Pereira

681017

Local Institution - 0098, Piedecuesta

710061

Local Institution - 0263, Xi'an

720237

Local Institution - 0026, Suceava

830000

Local Institution - 0311, Ürümqi

1720430

Local Institution - 0197, La Serena

2520598

Local Institution - 0018, Viña del Mar

6900941

Local Institution - 0318, Santiago

8330034

Local Institution - 0019, Santiago Region Metropolitana

74605070

Local Institution - 0287, Goiânia

06904

Local Institution - 0182, Stamford

04086

Local Institution - 0222, Topsham

07932

Local Institution - 0109, Florham Park

07601

Local Institution - 0050, Hackensack

08903

Local Institution - 0180, New Brunswick

C1417DTB

Local Institution - 0020, Buenos Aires

X5000FHP

Local Institution - 0294, Córdoba

C1280AEB

Local Institution - 0008, Capital Federal

S2002KDS

Local Institution - 0014, Rosario Santa Fe

X5000BAL

Local Institution - 0021, Córdoba

Unknown

Local Institution, La Rioja

Local Institution, Viedma

Local Institution - 0326, Antofagasta

Local Institution, Zhengzhou

Local Institution - 0034, Dublin

Local Institution - 0036, Cork

60135-237

Local Institution - 0130, Fortaleza

70200-730

Local Institution - 0225, Brasília

30130-100

Local Institution - 0133, Belo Horizonte

98700-000

Local Institution - 0132, Ijuí

90035-001

Local Institution - 0288, Porto Alegre

90050-170

Local Institution - 0131, Porto Alegre

90610-000

Local Institution - 0135, Porto Alegre

96830-180

Local Institution - 0273, Santa Cruz do Sul

14784-400

Local Institution - 0134, Barretos

09060-870

Local Institution - 0128, Santo André

01229-010

Local Institution - 0272, São Paulo

22793-080

Local Institution - 0129, Rio de Janeiro

01317-000

Local Institution - 0144, São Paulo

04378-500

Local Institution - 0104, São Paulo

H2X 0C1

Local Institution - 0095, Montreal

H3T 1E2

Local Institution - 0194, Montreal

J1H 5N4

Local Institution - 0058, Sherbrooke

080020

Local Institution - 0261, Barranquilla

054047

Local Institution - 0202, Rionegro

500 05

Local Institution - 0100, Hradec Králové

741 01

Local Institution - 0103, Nový Jičín

779 00

Local Institution - 0101, Olomouc

100 34

Local Institution - 0099, Prague

00029

Local Institution - 0001, Helsinki

01307

Local Institution - 0112, Dresden

04103

Local Institution - 0196, Leipzig

Dublin 9

Local Institution - 0035, Beaumont

00128

Local Institution - 0190, Roma

03100

Local Institution - 0168, Mexico City

1066 CX

Local Institution - 0033, Amsterdam

4818CK

Local Institution - 0177, Breda

7416 SE

Local Institution - 0199, Deventer

3584 CX

Local Institution - 0147, Utrecht

44-102

Local Institution - 0334, Gliwice

75-581

Local Institution - 0061, Koszalin

30-688

Local Institution - 0059, Krakow

93-338

Local Institution - 0063, Lodz

45-061

Local Institution - 0062, Opole

02-781

Local Institution - 0060, Warsaw

1500-650

Local Institution - 0210, Lisbon

1649-035

Local Institution - 0211, Lisbon

00716-0200

Local Institution - 0110, Ponce

011171

Local Institution - 0029, Bucharest

022328

Local Institution - 0025, Bucharest

Local Institution - 0270, Bucharest

03080

Local Institution - 0295, Seoul

03722

Local Institution - 0320, Seoul

05505

Local Institution - 0290, Seoul

06351

Local Institution - 0291, Seoul

03203

Local Institution - 0205, Elche

08035

Local Institution - 0171, Barcelona

08036

Local Institution - 0172, Barcelona

01060

Local Institution - 0073, Adana

06520

Local Institution - 0257, Ankara

07070

Local Institution - 0075, Antalya

M20 4BX

Local Institution - 0006, Withington

NW1 2BU

Local Institution - 0005, London

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY