A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

April 9, 2025

Primary Completion Date

January 29, 2028

Study Completion Date

May 30, 2032

Conditions
Breast Cancer
Interventions
DRUG

Inavolisib

Participants will receive oral inavolisib once daily (QD).

DRUG

Placebo

Participants will receive oral placebo QD.

DRUG

CDK4/6i

Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

DRUG

Letrozole

Participants will receive oral letrozole QD.

Trial Locations (154)

100

RECRUITING

National Taiwan Uni Hospital, Taipei

704

RECRUITING

National Cheng Kung Uni Hospital, Tainan City

2013

RECRUITING

Wits Clinical Research, Soweto

2065

RECRUITING

Royal North Shore Hospital, St Leonards

2192

RECRUITING

Linksfield Oncology Inc., Johannesburg

3900

RECRUITING

Abraham Oncology, Richards Bay

5112

RECRUITING

Lyell McEwin Hospital, Elizabeth Vale

10408

RECRUITING

National Cancer Center, Goyang-si

14000

RECRUITING

Instituto Nacional De Cancerologia, Distrito Federal

20089

RECRUITING

Istituto Clinico Humanitas, Rozzano

20132

RECRUITING

Ospedale San Raffaele, Milan

20133

RECRUITING

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20357

RECRUITING

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg

21401

RECRUITING

Velocity Clinical Research, Annapolis

22190

RECRUITING

Centre CARIO - HPCA, Plérin

24127

RECRUITING

Asst Papa Giovanni XXIII, Bergamo

28007

RECRUITING

IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica, Madrid

28040

RECRUITING

Hospital Clínico San Carlos, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28100

RECRUITING

University of Eastern Piedmont - Maggiore della Carità University Hospital, Novara

29011

RECRUITING

Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia, Málaga

30060

RECRUITING

Northwest Georgia Oncology Centers PC - Marietta, Marietta

31000

RECRUITING

Centro Estatal de Cancerologia de Chihuahua, Chihuahua City

31008

RECRUITING

Hospital de Navarra, Pamplona

31100

RECRUITING

Institut Universitaire de Cancer de Toulouse Oncopole, Toulouse

31151

RECRUITING

Soon Chun Hyang University Cheonan Hospital, Dongnam-gu, Cheonan-si

33240

RECRUITING

Mersin City Education and Research Hospital, Mersin

34070

RECRUITING

Centre Cancerologie Grand Montpellier, Montpellier

34147

RECRUITING

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul

34214

RECRUITING

Ba?c?lar Medipol Mega Üniversite Hastanesi, Istanbul

35042

RECRUITING

Centre Eugene Marquis, Rennes

35360

RECRUITING

Katip Celebi University Ataturk Training and Research Hospital, Izmir

38138

RECRUITING

West Cancer Center, Germantown

39100

RECRUITING

Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic, Bolzano

40138

RECRUITING

Policlinico S.Orsola-Malpighi, Bologna

40207

RECRUITING

Baptist Health Louisville, Louisville

40503

RECRUITING

Baptist Health Lexington, Lexington

40509

RECRUITING

Baptist Health Hamburg, Lexington

41100

RECRUITING

A.O. Universitaria Policlinico Di Modena, Modena

41404

RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

44280

RECRUITING

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44915

RECRUITING

Cleveland Clinic Foundation, Cleveland

45122

RECRUITING

Universitätsklinikum Essen, Essen

45136

RECRUITING

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH, Essen

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

47014

RECRUITING

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola

48013

RECRUITING

Hospital de Basurto, Bilbao

48149

RECRUITING

Universitätsklinikum Münster, Münster

49503

RECRUITING

Cancer & Hematology Centers of Western Michigan, Grand Rapids

50935

RECRUITING

St. Elisabeth Krankenhaus Köln GmbH, Cologne

56068

RECRUITING

InVO - Institut für Versorgungsforschung in der Onkologie GbR, Koblenz

57124

RECRUITING

Ospedale Civile - Livorno, Livorno

61801

RECRUITING

Carle Cancer Center, Urbana

62269

RECRUITING

Cancer Care Specialists of Central Illinois, O'Fallon

62702

RECRUITING

Springfield Clinic, Springfield

63225

RECRUITING

Dres. Andreas Köhler und Roswitha Fuchs, Langen

64132

RECRUITING

HCA Midwest Health, Kansas City

66113

RECRUITING

Caritas Klinik St. Theresia -Frauenklinik Brustzentrum, Saarbrücken

68020

RECRUITING

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

68803

RECRUITING

Nebraska Cancer Specialists, Grand Island

69007

RECRUITING

Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V., Ciudad de Huajuapan de León

69120

RECRUITING

Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg

73039

RECRUITING

Az. Osp. G. Panico, Tricase (LE)

80131

RECRUITING

A.O. Universitaria Federico II Di Napoli, Napoli

RECRUITING

U.O.C. Oncologia Medica Senologica, Napoli

81100

RECRUITING

A.O. S. Anna e San Sebastiano, Caserta

92069

RECRUITING

Kaiser Permanente - San Marcos, San Marcos

93053

RECRUITING

Caritas-Krankenhaus St. Josef, Regensburg

95045

RECRUITING

Humanitas Centro Catanese Di Oncologia, Misterbianco (CT)

97213

RECRUITING

Providence Portland Medical Center, Portland

97225

RECRUITING

Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy, Portland

98026

RECRUITING

Swedish Cancer Institute - Edmonds Campus, Edmonds

98104

RECRUITING

Swedish Cancer Institute - Issaquah, Seattle

RECRUITING

Swedish Cancer Institute, Seattle

98405

RECRUITING

Northwest Medical Specialties, Tacoma

100032

RECRUITING

Peking Union Medical College Hospital, Beijing

112019

RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

112201

RECRUITING

Taipei Veterans General Hospital, Taipei

150081

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

250117

RECRUITING

Shandong Cancer Hospital, Jinan

300000

RECRUITING

Tianjin Cancer Hospital, Tianjin

300300

RECRUITING

Tianjin Cancer hospital Airport hospital, Tianjin

310022

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

321083

RECRUITING

Jinhua municipal central hospital, Jinhua

407219

RECRUITING

Taichung Veterans General Hospital, Taichung

410013

RECRUITING

Hunan Cancer Hospital, Changsha

441106

RECRUITING

Xiangyang Central Hospital, Xiangyang

510060

RECRUITING

Sun yat-sen University Cancer Center, Guangzhou

515031

RECRUITING

Shantou Center Hospital, Shantou

529030

RECRUITING

Jiangmen Central Hospital, Jiangmen

530021

RECRUITING

Guangxi Cancer Hospital of Guangxi Medical University, Nanning

600566

RECRUITING

Chia-Yi Christian Hospital, Chiayi City

610041

RECRUITING

West China Hospital of Sichuan University, Chengdu

610072

RECRUITING

Sichuan Provincial People's Hospital, Chengdu

650118

RECRUITING

Yunnan Cancer Hospital, Kunming

710004

RECRUITING

The Second Affiliated Hospital of Xi'an Jiao Tong University, Xi'an

710068

RECRUITING

Shanxi Provincial People's Hospital, Xi'an

830011

RECRUITING

Xinjiang Medical University Cancer Hospital, Ürümqi

68130-2042

RECRUITING

Nebraska Cancer Specialists, Omaha

08816

RECRUITING

Astera Cancer Care East Brunswick, East Brunswick

C1426AGE

RECRUITING

Centro Oncologico Korben, Caba

C1414

RECRUITING

Centro Médico Fleischer, Capital Federal

X5016KEH

RECRUITING

Hospital Privado Centro Medico de Cordoba, Córdoba

S2013KZE

RECRUITING

Instituto de Oncologia de Rosario, Rosario

J5400

RECRUITING

Centro Oncológico de Excelencia, San Juan

60336-232

RECRUITING

Crio - Centro Regional Integrado de Oncologia, Fortaleza

29043-260

RECRUITING

Hospital Santa Rita de Cassia Vitoria, Vitória

40415-006

RECRUITING

Obras Sociais Irma Dulce - Osid, Salvador

74605-070

RECRUITING

Hospital Araujo Jorge, Goiânia

37130-087

RECRUITING

Centro de Oncologia de Alfenas, Alfenas

86015-520

RECRUITING

Hospital do Câncer de Londrina, Londrina

50040-000

RECRUITING

Hospital do Cancer de Pernambuco - HCP, Recife

64049-200

RECRUITING

Vencer Oncoclínica - Centro de Pesquisa do Piauí, Teresina

90020-090

RECRUITING

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

14784-400

RECRUITING

Hospital de Cancer de Barretos, Barretos

01246-000

RECRUITING

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

01317-001

RECRUITING

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo

20560-120

RECRUITING

Instituto Nacional de Cancer - INCa, Rio de Janeiro

E1C 6Z8

RECRUITING

The Moncton Hospital, Moncton

K1H 8L6

RECRUITING

The Ottawa Hospital Cancer Center, Ottawa

M6R 1B5

RECRUITING

St. Joseph's Health Centre, Toronto

H2X 0C1

RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal

H3T 1E2

RECRUITING

Jewish General Hospital, Montreal

J7Z 2V4

RECRUITING

Unité de Recherche Clinique du CISSS de Laurentides, Saint-Jérôme

Unknown

RECRUITING

Sun Yat-Sen University Cancer Center - Huangpu Campus, Guangzhou

RECRUITING

Hospital Zambrano Hellion TecSalud, Monterrey

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

05100

RECRUITING

A.O. Santa Maria Terni, Terni

04980

RECRUITING

Iem-Fucam, D.F.

93-338

RECRUITING

"Instytut Centrum Zdrowia Matki Polki", ?ód?

15-027

RECRUITING

Bialostockie Centrum Onkologii, Bialystok

62-500

RECRUITING

Przychodnia Lekarska KOMED, Roman Karaszewski, Konin

75-581

RECRUITING

Szpital Wojewódzki im. Miko?aja Kopernika, Koszalin

31-202

RECRUITING

Szpital Miejski Specjalistyczny Narutowicza, Krakow

20-090

RECRUITING

COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin

61-866

RECRUITING

Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie, Późna

35-021

RECRUITING

MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów

02-781

RECRUITING

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad, Warsaw

00935

RECRUITING

PanOncology Trials, San Juan

463-707

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06273

RECRUITING

Gangnam Severance Hospital, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

03203

RECRUITING

Hospital General Universitario de Elche, Elche

08908

RECRUITING

ICO L'Hospitalet, L'Hospitalet de Llobregat

08035

RECRUITING

Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

06200

RECRUITING

Abdurrahman Yurtarslan Onkoloji Training and Research Hospital, Ankara

06800

RECRUITING

Ankara City Hospital, Ankara

CM20 1QX

RECRUITING

Princess Alexandra Hospital, Harlow

EC1M 6BQ

RECRUITING

St Bartholomew's Hospital, London

NW3 2QG

RECRUITING

Royal Free Hospital, London

OX3 7LE

RECRUITING

Churchill Hospital - Oxford Cancer & Haematology Centre, Oxford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY