A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Inavolisib; Drug: Palbociclib; Drug: Fulvestrant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WO41554 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundación CENIT para la Investigación en Neurociencias
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben; Oncology
  • Rosario, Argentina, S2002KDS
    • Hosp Provincial D. Centenarios; Oncology Dept
  • Viedma, Argentina, R8500ACE
    • Clinica Viedma S.A.
• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie University Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital; Medical Oncology and Pallative Care
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Centre
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital; Oncology
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital; Cancer Trials Unit
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Western Health
    • Frankston, Victoria, Australia, 3199
      • Peninsula and South Eastern Haematology and Oncology Group
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Brazil
  • GO
    • Goiania, GO, Brazil, 74605-070
      • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Santa Casa de Misericordia de Porto Alegre
  • SP
    • Sao Paulo, SP, Brazil, 01317-001
      • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre-Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program, London Health Sciences Centre, Baines Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Center
  • Quebec
    • Quebec City, Quebec, Canada, G1S 4L8
      • Hopital du Saint Sacrement
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun City, China, 130021
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chongqing, China, 400016
    • The First Affiliated Hospital, Chongqing Medical University
  • Fuzhou City, China, 350001
    • Fujian Medical University Union Hospital
  • Guangzhou City, China, 510663
    • Sun Yet-sen University Cancer Center
  • Hangzhou City, China, 310022
    • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Nanjing City, China, 210029
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Shanghai City, China, 201315
    • Fudan University Shanghai Cancer Center; Medical Oncology
  • Shijiazhuang, China, 050035
    • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Wuhan City, China, 430023
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Denmark
  • Vejle, Denmark, 7100
    • Vejle Sygehus; Onkologisk Afdeling
• France
  • Clermont-ferrand, France, 63003
    • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc; Oncologie 3
  • Lille, France, 59020
    • Centre Oscar Lambret; Senologie
  • Limoges, France, 87042
    • Hopital Dupuytren; Oncologie Medicale
  • Lyon, France, 69373
    • Hopital Prive Jean Mermoz; Cancerologie
  • Montpellier, France, 34298
    • Institut régional du Cancer Montpellier
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer de Toulouse-Oncopole
• Georgia
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla
  • Tbilisi, Georgia, 0159
    • Cancer Research Centre
  • Tbilisi, Georgia, 0112
    • Acad. F. Todua Medical Center
  • Tbilisi, Georgia, 0159
    • Tbilisi Oncology Dispensary
  • Tbilisi, Georgia, 179
    • S Khechinashvili University Clinic Ltd
  • Tbilisi, Georgia, 0112
    • Israel-Georgian Medical Research Clinic Healthycore
• Germany
  • Berlin, Germany, 13581
    • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
  • Essen, Germany, 45136
    • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Heidelberg, Germany, 69120
    • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim; Frauenklinik
  • Trier, Germany, 54290
    • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
  • Ulm, Germany, 89075
    • Universitätsfrauenklinik Ulm; Abteilung Gynäkologie
• Greece
  • Athens, Greece, 115 22
    • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki; Oncology Department
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital; Dept of Medicine
  • Shatin, Hong Kong
    • Prince of Wales Hospital; Department of Clinical Onocology
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Korhaz; Onkoradiológiai Osztály
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
  • Szolnok, Hungary, 5004
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43100
      • A.O. Universitaria Di Parma
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
      • Irccs Centro Di Riferimento Oncologico (CRO)
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Azienda Ospedaliera Univ di Udine; Oncologia Medica
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
    • Milano, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Toscana
    • Bagno a Ripoli, Toscana, Italy, 50012
      • Ospedale Santa Maria Annunziata; Oncologia
    • Pisa, Toscana, Italy, 56126
      • Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center
  • Goyang-si, Korea, Republic of, 10408
    • National Cancer Center
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
• Malaysia
  • Sarawak, Malaysia, 93586
    • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
  • FED. Territory OF Kuala Lumpur
    • Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre; Clinical Oncology Unit,
  • Federal Territory OF Putrajaya
    • Putrajaya, Federal Territory OF Putrajaya, Malaysia, 62250
      • National Cancer Institute IKN
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail; Oncology
• New Zealand
  • Palmerston North, New Zealand, 4442
    • Palmerston North Hospital; Regional Cancer Treatment Service
• Poland
  • ?ód?, Poland, 90-338
    • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • Gliwice, Poland, 44-102
    • Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Opole, Poland, 45-061
    • Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym
  • Torun, Poland, 87-100
    • Lecznice Citomed Sp. z o.o.
  • Warszawa, Poland, 02-781
    • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny; Klinika Onkologii
• Portugal
  • Lisboa, Portugal, 1400-038
    • Centro Clinico Champalimaud; Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Russian Federation
  • Volgograd, Russian Federation, 400138
    • Volgograd Regional Clinical Oncology Dispensary
  • Yaroslavl, Russian Federation, 150040
    • Regional Clinical Oncology Hospital
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 143422
      • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
    • Moscow, Moskovskaja Oblast, Russian Federation, 111123
      • Moscow Clinical Scientific Center
    • Moscow, Moskovskaja Oblast, Russian Federation, 115552
      • Blokhin Cancer Research Center; Out-Patients Dept
    • Moskva, Moskovskaja Oblast, Russian Federation, 119421
      • LLC Medscan
    • Yudino, Moskovskaja Oblast, Russian Federation, 143081
      • Clinical Hospital Lapino (LLC Haven)
  • Sankt Petersburg
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 196006
      • Medical Clinic "AB Medical group"
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • Singapore, Singapore, 168583
    • National Cancer Centre; Medical Oncology
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Oncologia
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
  • Barcelona, Spain, 08035
    • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Barcelona, Spain, 08907
    • Insituto Catalán de Oncologia (ICO)
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra-Madrid
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Oncologia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Oncologia
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
  • Tainan, Taiwan, 710
    • Chi-Mei Medical Centre; Hematology & Oncology
  • Taipei, Taiwan, 00112
    • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • Taipei, Taiwan, 100
    • National Taiwan Uni Hospital; General Surgery
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital, Division of General Surgery
  • Taipei City, Taiwan, 11259
    • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
  • Lak Si, Thailand, 10210
    • Chulabhorn Hospital; Medical Oncology
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital; Department of Oncology
• Turkey
  • Adana, Turkey, 01120
    • Adana Baskent University Hospital; Medical Oncology
  • Ankara, Turkey, 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey, 06010
    • Gulhane Training and Research Hospital
  • Bornova, ?zm?r, Turkey, 35100
    • Ege University Medical Faculty; Medical Oncology Department
  • Istanbul, Turkey, 34384
    • Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Faculty of Medicine
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • City Clinical Hospital #4
  • Kryvyi Rih, Ukraine, 50048
    • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncological Center
  • Sumy, Ukraine, 40005
    • RCI Sumy Regional Clinical Oncological Dispensary
  • KIEV Governorate
    • Ivano-Frankivsk, KIEV Governorate, Ukraine, 76018
      • Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
    • Uzhhorod, KIEV Governorate, Ukraine, 88000
      • Uzhhorod Central City Clinical Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61018
      • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
• United Kingdom
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Royal Infirmary
  • Harlow, United Kingdom, CM20 1QX
    • Princess Alexandra Hospital; Oncology Department
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital - Fulham; Oncology Department
  • London, United Kingdom, SW17 0RE
    • St Georges University Hospitals NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust; Cancer Research Delivery Group
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital; Kent Oncology Centre
  • Manchester, United Kingdom, M20 4BX
    • Christie Foundation Trust
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Hospital; Mount Vernon Cancer Centre
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital; Department of Oncology
  • Peterborough, United Kingdom, PE3 9GZ
    • Peterborough City Hospital, Edith Cavell Campus; Oncology Department
  • Plymouth, United Kingdom, PL6 8BT
    • Derriford Hospital
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
  • Florida
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Winship Cancer Institute of Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital.
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Sarah Cannon Research Institute / Tennessee Oncology
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology - Nashville
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Onc-Central Austin CA Ct
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center; Department of Internal Medicine
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Northeast Texas
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Confirmed diagnosis of HR+/HER2- breast cancer
• Metastatic or locally advanced disease not amenable to curative therapy
• Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
• Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
• Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
• Consent to provide fresh or archival tumor tissue specimen
• Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Life expectancy of > 6 months
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion Criteria

• Metaplastic breast cancer
• Any history of leptomeningeal disease or carcinomatous meningitis
• Any prior systemic therapy for metastatic breast cancer
• Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
• Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
• Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
• Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
• Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
• Symptomatic active lung disease, or requiring daily supplemental oxygen
• History of inflammatory bowel disease or active bowel inflammation
• Anti-cancer therapy within 2 weeks before study entry
• Investigational drug(s) within 4 weeks before randomization
• Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
• Chronic corticosteroid therapy or immunosuppressants
• Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
• Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inavolisib + Palbociclib + Fulvestrant; Participants will receive inavolisib, palbociclib, and fulvestrant.	Drug: Inavolisib; Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.; Other Names: GDC-0077; 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.
Placebo Comparator: Placebo + Palbociclib + Fulvestrant; Participants will receive placebo, palbociclib, and fulvestrant.	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.; Drug: Placebo; Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival (PFS)	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Up to 6 years
Best Overall Response Rate (BOR)	Up to 6 years
Duration of Response (DOR)	From the first occurrence of a CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)
Clinical Benefit Rate (CBR)	Up to 6 years
Overall Survival (OS)	From randomization to death from any cause (up to 6 years)
Time to Deterioration (TTD) in Pain	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
TTD in Physical Function	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
TTD in Role Function	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
TTD in Global Health Status	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
Percentage of Participants with Adverse Events	From randomization through the end of study (up to 6 years)
Plasma Concentration of Inavolisib	At pre-defined intervals from baseline to the end of study (up to 6 years)
Plasma Concentration of Palbociclib	At pre-defined intervals from baseline to the end of study (up to 6 years)
Plasma Concentration of Fulvestrant	At pre-defined intervals from baseline to the end of study (up to 6 years)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): September 29, 2023
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protein Kinase Inhibitors; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Phosphoinositide-3 Kinase Inhibitors; Fulvestrant; Palbociclib; Inavolisib
• Other Study ID Numbers: WO41554; 2019-002455-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No