A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Breast Cancer Clinical Trial

— INAVO121  

Official title:

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646862
• Other study ID #: WO43919
• Secondary ID: 2022-502322-41-0
• Status: Recruiting
• Phase: Phase 3
• Start date: June 7, 2023
• Est. completion date: March 30, 2029

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: WO43919 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 30, 2029
• Est. primary completion date: March 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1

• Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent

• Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines

• Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test

• Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed

• Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

• Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

• Life expectancy of > 6 months

• Adequate hematologic and organ function prior to initiation of study treatment

Exclusion Criteria:

• Metaplastic breast cancer

• Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway

• Participant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease

• Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment

• Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

• Inability or unwillingness to swallow pills

• Malabsorption syndrome or other condition that would interfere with enteral absorption

• Any history of leptomeningeal disease or carcinomatous meningitis

• Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria

• Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1

• Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition

• Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

• Requirement for daily supplemental oxygen

• Symptomatic active lung disease, including pneumonitis

• History of or active inflammatory bowel disease

• Any active bowel inflammation

• Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis

• Participants with known human immunodeficiency virus infection that meet specific criteria

• Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer

• History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence

• Chronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease

• Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations

• History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms

• Active ongoing osteonecrosis of the jaw

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Inavolisib
Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle.
• Fulvestrant
Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle.
• Alpelisib
Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.

Locations

Country	Name	City	State
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Argentina	Centro Oncologico Korben; Oncology	Ciudad Autonoma Buenos Aires
Argentina	Fundacion CORI para la Investigacion y Prevencion del Cancer	La Rioja
Argentina	Hosp Provincial D. Centenarios; Oncology Dept	Rosario
Argentina	Instituto de Oncología de Rosario	Rosario
Argentina	Sanatorio Parque S.A.	Rosario
Argentina	CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica	San Juan
Argentina	Clinica Viedma S.A.	Viedma
Australia	Icon Cancer Care Wesley	Auchenflower	Queensland
Australia	Bendigo Cancer Centre	Bendigo	Victoria
Australia	Campbelltown Hospital; Macarthur Cancer Therapy Centre	Campbelltown	New South Wales
Australia	Coffs Harbour Health Campus	Coffs Harbour	New South Wales
Australia	Concord Repatriation General Hospital; Concord Cancer Centre	Concord	New South Wales
Australia	Kinghorn Cancer Centre; St Vincents Hospital	Darlinghurst	New South Wales
Australia	Gosford Hospital; Cancer Care Services	Gosford	New South Wales
Australia	Sir Charles Gairdner Hospital; Medical Oncology	Perth	Western Australia
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	GHdC Site Notre Dame	Charleroi
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	Clinique Ste-Elisabeth	Namur
Brazil	NUPEC	Belo Horizonte	MG
Brazil	Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR	Brasilia	DF
Brazil	Hospital Santa Cruz / Centro de Oncologia D'Or	Curitiba	PR
Brazil	Liga Norte Riograndense Contra O Câncer	Natal	RN
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Hospital do Cancer de Pernambuco - HCP	Recife	PE
Brazil	Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife	Recife	PE
Brazil	Hospital da Bahia	Salvador	BA
Brazil	Hospital de Base de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP
Brazil	Hospital Sírio-Libanês	Sao Paulo	SP
Brazil	Vencer Oncoclínica - Centro de Pesquisa do Piauí	Teresina	PI
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont	Montreal	Quebec
Canada	Hôpital du Sacré-Coeur de Montreal	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	BC Cancer ? Vancouver	Vancouver	British Columbia
China	The First Hospital of Jilin University	Changchun City
China	Sichuan Provincial Cancer Hospital	Chengdu
China	The First Affiliated Hospital, Chongqing Medical University	Chongqing
China	Sun yat-sen University Cancer Center; Internal Medicine of Oncology	Guangzhou
China	Guangdong Provincial People's Hospital; Breast	Guangzhou City
China	Sir Run Run Shaw Hospital Zhejiang University	Hangzhou City
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou City
China	Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy	Harbin
China	Shandong Cancer Hospital	Jinan
China	The Second Affiliated Hospital to Nanchang University	Nanchang
China	Jiangsu Cancer Hospital	Nanjing City
China	Tianjin Cancer Hospital; Department of Breast Oncology	Tianjin
China	Hubei Cancer Hospital	Wuhan
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	Zhejiang Cancer Hospital	Zhejiang
France	Centre Hospitalier de La Cote Basque; Oncologie	Bayonne
France	Polyclinique Bordeaux Nord	Bordeaux
France	Centre Leon Berard; Service Oncologie Medicale	Lyon
France	ICM; Medecine B3	Montpellier cedex 5
France	IUCT Oncopole	Toulouse
Germany	Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin	Aachen
Germany	Onkologische Schwerpunktpraxis Bielefeld	Bielefeld
Germany	Universitätsklinikum Essen; Zentrum Für Frauenheilkunde	Essen
Germany	Praxis für Interdisziplinäre Onkologie und Hämatologie GbR	Freiburg
Germany	Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH	Georgsmarienhütte
Germany	Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Gynäkologie und Geburtshilfe	Göttingen
Germany	Mammazentrum Hamburg am Krankenhaus Jerusalem	Hamburg
Germany	Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie	Hannover
Germany	Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg	Heidelberg
Germany	Brustzentrum Rhein-Ruhr Servicegesellschaft mbH	Mönchengladbach
Germany	Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt	München
Germany	St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise	Paderborn
Germany	Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg	Ravensburg
Italy	ASL AL - Azienda Sanitaria Locale AL; S.C. Oncologia	Alessandria	Piemonte
Italy	Irccs Centro Di Riferimento Oncologico (CRO)	Aviano	Friuli-Venezia Giulia
Italy	A.O. S. Anna e San Sebastiano; Oncologia	Caserta	Campania
Italy	Ospedale S. Giuseppe; Oncologia	Empoli (FI)	Toscana
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Ospedale San Raffaele; Medical Oncology	Milano	Lombardia
Italy	Humanitas Centro Catanese Di Oncologia; Oncologia Medica	Misterbianco (CT)	Sicilia
Italy	AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia	Ravenna	Emilia-Romagna
Italy	AOU Città della Salute e della Scienza di Torino	Torino	Piemonte
Italy	Ospedale Santa Chiara; Oncologia Medica	Trento	Trentino-Alto Adige
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Catholic Univ. of Incheon St.Mary's Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	ARKE Estudios Clínicos S.A. de C.V.	Ciudad de México
Mexico	COI Centro Oncologico Internacional Santa Fe	Ciudad de México	Mexico CITY (federal District)
Mexico	OncoMed; Supportive Care	Ciudad de México	Mexico CITY (federal District)
Mexico	Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Panamerican Clinical Research S.A de C.V.	Guadalajara	Jalisco
Mexico	RENATI INNOVATION S.A.P.I. de C.V	Guadalajara	Jalisco
Mexico	CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO	Mexico City
Mexico	Instituto Nacional de Cancerologia; Oncology	Mexico City
Poland	Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii	Bydgoszcz
Poland	Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny	Gdynia
Poland	Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi	Gliwice
Poland	Przychodnia Lekarska KOMED, Roman Karaszewski	Konin
Poland	Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii	Koszalin
Poland	Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna	Kraków
Poland	MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie	Rzeszow
Poland	Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr	Warszawa
South Africa	Dr. W.M. Szpak Incorporated trading as Rainbow Oncology	Durban
South Africa	Hopelands Cancer Centre	Hilton
South Africa	Medical Oncology Centre of Rosebank; Oncology	Johannesburg
South Africa	Richards Bay Oncology Centre	KwaZulu Natal
Spain	Hospital Universitari Vall d'Hebron; Oncology	Barcelona
Spain	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres
Spain	ICO L'Hospitalet; Servicio de oncologia medica	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga
Spain	Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia	Murcia
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Virgen Macarena; Servicio de Oncologia	Sevilla
Taiwan	China Medical University Hospital; Surgery	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hosipital at Linkou	Taoyuan City
Taiwan	Veterans General Hospital - Taichung	Xitun Dist.
Taiwan	National Taiwan University Hospital; Oncology	Zhongzheng Dist.
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital; Department of Medicine	ChiangMai
Thailand	Songklanagarind Hospital; Department of Oncology	Songkhla
Turkey	Gulhane Training and Applicaton Hospital	Ankara
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Dicle University Faculty of Medicine	Diyarbakir
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Marmara Uni Faculty of Medicine; Medical Oncology	Istanbul
Turkey	Medipol Mega Üniversite Hastanesi Göztepe	Istanbul
Turkey	Ege Uni Medical Faculty Hospital; Oncology Dept	Izmir
Turkey	Katip Celebi University Ataturk Training and Research Hospital; Oncology	Izmir
Turkey	Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology	Kadiköy
Turkey	Medical Park Seyhan Hospital; Oncology Department	Seyhan
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
United Kingdom	Basingstoke and North Hampshire Hospital	Basingstoke
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Dumfries and Galloway Royal Infirmary	Dumfries
United Kingdom	Western General Hospital; Clinical Oncology	Edinburgh
United Kingdom	Princess Alexandra Hospital	Harlow
United Kingdom	St John's Hospital	Livingston
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Maidstone & Tonbridge Wells Hospital; Kent Oncology Center	Maidstone
United Kingdom	Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology	Northwood
United Kingdom	Churchill Hospital; Department of Oncology	Oxford
United Kingdom	Royal Preston Hosptial	Preston
United Kingdom	ROYAL HAMPSHIRE COUNTY HOSPITAL; R&D Office	Winchester
United States	Texas Oncology West	Amarillo	Texas
United States	Emory University Hospital	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	Midtown West Medical	Atlanta	Georgia
United States	Winship Cancer Institute at Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Consultants in Medical Oncology and Hematology	Broomall	Pennsylvania
United States	Gabrail Cancer Center	Canton	Ohio
United States	Novant Health Presbyterain Medical Center	Charlotte	North Carolina
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Karmanos Cancer Institute.	Detroit	Michigan
United States	Texas Tech University Health Sciences Center; Department of Internal Medicine	El Paso	Texas
United States	Texas Oncology (Flower Mound) - USOR	Flower Mound	Texas
United States	The Center for Cancer and Blood Disorders - Fort Worth	Fort Worth	Texas
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Marin Cancer Care Inc	Greenbrae	California
United States	Kadlec Clinic Hematology and Oncology	Kennewick	Washington
United States	Lumi Research	Kingwood	Texas
United States	Cancer Blood and Specialty Clinic	Los Alamitos	California
United States	Los Angeles Cancer Network	Los Angeles	California
United States	University of Louisville Hospital; The James Graham Brown Cancer Center	Louisville	Kentucky
United States	Texas Oncology McKinney	McKinney	Texas
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	Eastern CT Hematology and Oncology Associates	Norwich	Connecticut
United States	University of California, Irvine Medical Center	Orange	California
United States	Cancer Care Centers of Brevard	Rockledge	Florida
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Minnesota Oncology Hematology	Saint Paul	Minnesota
United States	Abramson Cancer Center Chester County Hospital; Hematology, Medical Oncology	West Chester	Pennsylvania
United States	Cleveland Clinic Florida	Weston	Florida
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	WellSpan Oncology Research	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  France,  Germany,  Italy,  Korea, Republic of,  Mexico,  Poland,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)		From randomization until disease progression or death due to any cause (up to approximately 64 months)
Secondary	Overall survival (OS)		From randomization until death due to any cause (up to approximately 85 months)
Secondary	BICR-Assessed Overall Response Rate (ORR)		Up to approximately 64 months
Secondary	BICR-Assessed Best Overall Response (BOR)		Up to approximately 64 months
Secondary	BICR-Assessed Clinical Benefit Rate (CBR)		Up to approximately 64 months
Secondary	BICR-Assessed Duration of Response (DOR)		From CR or PR until disease progression or death due to any cause (up to approximately 64 months)
Secondary	Time to Confirmed Deterioration (TTCD) in Pain		Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Secondary	TTCD in Physical Functioning		Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Secondary	TTCD in Role Functioning		Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Secondary	TTCD in Global Health Status/Quality of Life (QOL)		Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.
Secondary	Percentage of Participants with Adverse Events		Day 1 until 30 days after the final dose of study treatment (up to approximately 85 months)
Secondary	Plasma Concentration of Inavolisib at Specified Timepoints		Day 1 and 15 of Cycle 1, and Day 1 of Cycles 2 and 3. Each cycle is 28 days.