A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

January 29, 2020

Primary Completion Date

September 29, 2023

Study Completion Date

November 15, 2027

Conditions
Breast Cancer
Interventions
DRUG

Inavolisib

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

DRUG

Placebo

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

DRUG

Palbociclib

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

DRUG

Fulvestrant

Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

Trial Locations (133)

100

National Taiwan Uni Hospital, Taipei

112

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

114

Tri-Service General Hospital, Division of General Surgery, Taipei

807

Kaohsiung Medical Uni Chung-Ho Hospital, Kaohsiung City

1122

Orszagos Onkologiai Intezet, Budapest

1145

Uzsoki Utcai Korhaz, Budapest

2109

Macquarie University Hospital, Macquarie Park

2500

Southern Medical Day Care Centre, Wollongong

3000

UZ Leuven Gasthuisberg, Leuven

3065

Western Health, Fitzroy

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

4101

Mater Adult Hospital, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4442

Palmerston North Hospital, Palmerston North

5004

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok

6351

Samsung Medical Center, Seoul

7100

Vejle Sygehus, Vejle

10065

Memorial Sloan Kettering Cancer Center, New York

10210

Chulabhorn Hospital, Lak Si

10400

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Gyeonggi-do

13581

Ambulantes Tumorzentrum Spandau, Berlin

13620

Seoul National University Bundang Hospital, Gyeonggi-do

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

21079

Centre Georges Francois Leclerc, Dijon

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico, Jaén

25123

Az. Osp. Spedali Civili, Brescia

28007

Hospital General Universitario Gregorio Marañon, Madrid

28027

Clinica Universidad de Navarra-Madrid, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro, Madrid

31008

Clinica Universitaria de Navarra, Pamplona

31059

Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse

34098

Istanbul University Cerrahpasa Faculty of Medicine, Istanbul

34298

Institut régional du Cancer Montpellier, Montpellier

34384

Prof. Dr. Cemil Tascioglu City Hospital, Istanbul

35100

Ege University Medical Faculty, Bornova, ?zm?r

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

37403

Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

41009

Hospital Universitario Virgen Macarena, Seville

41404

Kyungpook National University Medical Center, Daegu

43100

A.O. Universitaria Di Parma, Parma

45136

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

46009

Instituto Valenciano Oncologia, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

49102

City Clinical Hospital #4, Dnipropetrovsk

49241

Pusan National University Hospital, Busan

50012

Ospedale Santa Maria Annunziata, Bagno a Ripoli

50048

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council, Kryvyi Rih

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

54290

Klinikum Mutterhaus der Borromaeerinnen gGmbH, Trier

59020

Centre Oscar Lambret, Lille

61018

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU, Kharkiv

62250

National Cancer Institute IKN, Putrajaya

63003

Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne, Clermont-Ferrand

68167

Universitätsklinikum Mannheim, Mannheim

69120

Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg

69373

Hopital Prive Jean Mermoz, Lyon

75702

Texas Oncology - Northeast Texas, Tyler

76018

Municipal Institution SubCarpathian Clinical Oncological Centre, Ivano-Frankivsk

78731

Texas Oncology - Central South, Austin

79905

Texas Tech University Health Sciences Center, El Paso

81100

Hospital Sultan Ismail, Johor Bahru

88000

Uzhhorod Central City Clinical Hospital, Uzhhorod

89075

Universitätsfrauenklinik Ulm, Ulm

90110

Songklanagarind Hospital, Songkhla

90211

Beverly Hills Cancer Center, Beverly Hills

93586

Sarawak General Hospital, Sarawak

98405

Northwest Medical Specialties, Tacoma

100142

Beijing Cancer Hospital, Beijing

111123

Moscow Clinical Scientific Center, Moscow

115552

Blokhin Cancer Research Center, Moscow

119421

LLC Medscan, Moskva

130021

The First Hospital of Jilin University, Changchun

143081

Clinical Hospital Lapino (LLC Haven), Yudino

150040

Regional Clinical Oncology Hospital, Yaroslavl

150081

Harbin Medical University Cancer Hospital, Harbin

168583

National Cancer Centre, Singapore

197082

"Medical Clinic AB Medical group", Saint Petersburg

201315

Fudan University Shanghai Cancer Center, Shanghai

300060

Tianjin Cancer Hospital, Tianjin

310022

Zhejiang Cancer Hospital, Hangzhou

350001

Fujian Medical University Union Hospital, Fujian

400016

The First Affiliated Hospital, Chongqing Medical University, Chongqing

400138

Volgograd Regional Clinical Oncology Dispensary, Volgograd

430079

Hubei Cancer Hospital, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510060

Sun Yet-sen University Cancer Center, Guangzhou

625000

Przychodnia Lekarska KOMED, Roman Karaszewski, Konin

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

02114

Massachusetts General Hospital., Boston

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

C1426AGE

Centro Oncologico Korben, Ciudad Autonoma Buenos Aires

S2002KDS

Hosp Provincial D. Centenarios, Rosario

90050-170

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

T2N 5G2

Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary

N6A 4L6

London Regional Cancer Program, London Health Sciences Centre, Baines Centre, London

K1H 8L6

Ottawa Hospital, Ottawa

M5G 1Z5

Princess Margaret Cancer Center, Toronto

G1S 4L8

Hopital du Saint Sacrement, Québec

050035

Hebei Medical University Fourth Hospital, Shijiazhuang

0112

Israel-Georgian Medical Research Clinic Healthycore, Tbilisi

0159

Tbilisi Oncology Dispensary, Tbilisi

115 22

Anticancer Hospital Ag. Savas, Athens

711 10

Univ General Hosp Heraklion, Heraklion

546 45

Euromedical General Clinic of Thessaloniki, Thessaloniki

570 01

European Interbalkan Medical Center, Thessaloniki

Unknown

Queen Mary Hospital, Hong Kong

44-102

Narodowy Instytut Onkologii Odzia? w Gliwicach, Gliwice

02-781

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

1400-038

Centro Clinico Champalimaud, Lisbon

4200-072

IPO do Porto, Porto

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

07985

Ewha Womans University Mokdong Hospital, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08035

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

08907

Insituto Catalán de Oncologia (ICO), Barcelona

00112

Veterans General Hospital, Taipei

01120

Adana Baskent University Hospital, Adana

06010

Gulhane Training and Research Hospital, Ankara

03115

Kyiv City Clinical Oncological Center, Kyiv

SW3 6JJ

Royal Marsden Hospital - Fulham, London

HA6 2RN

Mount Vernon Hospital, Northwood

OX3 7LJ

Churchill Hospital, Oxford

PL6 8DH

Derriford Hospital, Plymouth

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY