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NCT05646862

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2023-06-07

Completion Date

2029-03-30

Last Updated

2026-02-05

Healthy Volunteers

Conditions

Breast Cancer

Interventions

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 of main study and sub-study.

DRUG

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 of main study and sub-study.

DRUG

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.

DRUG

Bupropion

Participants will be administered bupropion PO on Day -3 and Day 12 of Cycle 1 of the sub-study.

DRUG

Omeprazole

Participants will be administered omerprazole PO on Day -4 and Day 11 of Cycle 1 of sub-study.

DRUG

Midazolam

Participants will be administered midazolam PO on Day -4 and Day 11 of Cycle 1 of sub-study.

Inclusion Criteria for Main Study and Sub-study: * 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 for both Main Study and Sub-study: * 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 * 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 * 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 * 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 * Active ongoing osteonecrosis of the jaw Exclusion Criteria for Main Study Only: * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment * 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 * Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer * 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 Exclusion Criteria for Sub-study Only: * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the substudy or within 2 weeks after the final dose of inavolisib and within 2 years after the final dose of fulvestrant, whichever is longer * 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 -4 of Cycle 1 * Investigational drug(s) within 4 weeks prior to Day -4 or within 5 half-lives of the investigational drug(s), whichever is longer * Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant formulations * Treatment with mild, moderate, or strong inducers of CYP2B6, CYP3A4, and/or CYP2C19 (including St. John's Wort) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1 * Treatment with mild, moderate, or strong inhibitors of CYP2B6, CYP3A4, and/or CYP2C19 (including grapefruit juice or supplements) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1

Locations (145)

Cancer Blood and Specialty Clinic

Los Alamitos, California, United States

Los Angeles Cancer Network

Los Angeles, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Cleveland Clinic Florida

Weston, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Midtown West Medical

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Winship Cancer Institute at Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Minnesota Oncology Hematology

Saint Paul, Minnesota, United States

Asante Rogue Regional Medical Center

Medford, Oregon, United States

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Fundacion CORI para la Investigacion y Prevencion del Cancer

La Rioja, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Hosp Provincial D. Centenarios

Rosario, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Clinica Viedma S.A.

Viedma, Argentina

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Icon Cancer Care Wesley

Auchenflower, Queensland, Australia

Bendigo Cancer Centre

Bendigo, Victoria, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Cliniques Universitaires St-Luc

Brussels, Belgium

GHdC Site Les Viviers

Charleroi, Belgium

UZ Antwerpen

Edegem, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Clinique Ste-Elisabeth

Namur, Belgium

NUPEC

Belo Horizonte, Minas Gerais, Brazil

Hospital Santa Cruz / Centro de Oncologia D'Or

Curitiba, Paraná, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife

Recife, Pernambuco, Brazil

Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

BC Cancer ? Vancouver

Vancouver, British Columbia, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada

The First Hospital of Jilin University

Changchun, China

Sichuan Provincial Cancer Hospital

Chengdu, China

Sun yat-sen University Cancer Center

Guangzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, China

Harbin Medical University Tumor Hospital

Harbin, China

The Second Affiliated Hospital to Nanchang University

Nanchang, China

Jiangsu Cancer Hospital

Nanjing, China

Tianjin Cancer Hospital

Tianjin, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Hubei Cancer Hospital

Wuhan, China

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

Xi'an, China

Zhejiang Cancer Hospital

Zhejiang, China

Centre Hospitalier de La Cote Basque

Bayonne, France

Centre Leon Berard

Lyon, France

ICM

Montpellier, France

Centre Eugene Marquis

Rennes, France

IUCT Oncopole

Toulouse, France

Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin

Aachen, Germany

Universitätsklinikum Essen

Essen, Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, Germany

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

Hanover, Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

Mönchengladbach, Germany

St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise

Paderborn, Germany

A.O. S. Anna e San Sebastiano

Caserta, Campania, Italy

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

Meldola, Emilia-Romagna, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

Ospedale Santa Chiara

Trento, Trentino-Alto Adige, Italy

Panamerican Clinical Research S.A de C.V.

Guadalajara, Jalisco, Mexico

RENATI INNOVATION S.A.P.I. de C.V

Guadalajara, Jalisco, Mexico

COI Centro Oncologico Internacional Santa Fe

Mexico City, Mexico CITY (federal District), Mexico

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

OncoMed

Mexico City, Mexico CITY (federal District), Mexico

ARKE Estudios Clínicos S.A. de C.V.

Mexico City, Mexico CITY (federal District), Mexico

Instituto Nacional de Cancerologia

Distrito Federal, Mexico

CENEIT Oncologicos

Mexico City, Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Morelia, Mexico

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

Bydgoszcz, Poland

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, Poland

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

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

Rzeszów, Poland

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warsaw, Poland

Medical Oncology Centre of Rosebank

Johannesburg, South Africa

Richards Bay Oncology Centre

KwaZulu Natal, South Africa

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Inha University Hospital

Incheon, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St Mary's Hospital

Seoul, South Korea

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital San Pedro De Alcantara

Cáceres, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional Universitario Carlos Haya

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hosipital at Linkou

Taoyuan, Taiwan

Veterans General Hospital - Taichung

Xitun Dist., Taiwan

National Taiwan University Hospital

Zhongzheng Dist., Taiwan

Gulhane Training and Applicaton Hospital

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Medipol Mega Üniversite Hastanesi Göztepe

Istanbul, Turkey (Türkiye)

Marmara Uni Faculty of Medicine

Istanbul, Turkey (Türkiye)

Ege Uni Medical Faculty Hospital

Izmir, Turkey (Türkiye)

Katip Celebi University Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Goztepe Prof.Dr. Suleyman Yalcin City Hospital

Kadiköy, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital

Sihhiye/Ankara, Turkey (Türkiye)

Basingstoke and North Hampshire Hospital

Basingstoke, United Kingdom

Blackpool Victoria Hospital

Blackpool, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Princess Alexandra Hospital

Harlow, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

Maidstone & Tonbridge Wells Hospital

Maidstone, United Kingdom

Mount Vernon & Watford Hospital Trust

Northwood, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Royal Hampshire County Hospital

Winchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (145)