A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Registration Number
NCT05894239
Lead Sponsor
Hoffmann-La Roche
Brief Summary

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
230
Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
  • Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
  • Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months
  • LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
  • Adequate hematologic and organ function prior to initiation of study treatment
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Exclusion Criteria
  • Prior treatment in the 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
  • Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
  • History or active inflammatory bowel disease
  • Disease progression within 6 months of receiving any HER2-targeted therapy
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Participants with active HBV infection
  • Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Symptomatic active lung disease, including pneumonitis or interstitial lung disease
  • Any history of leptomeningeal disease or carcinomatous meningitis
  • Serious infection requiring IV antibiotics 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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Maintenance Therapy: Inavolisib plus PhesgoPhesgoParticipants will be administered the treatments as outlined in the interventions section.
Induction Therapy: Phesgo plus Taxane-Based ChemotherapyPhesgoParticipants will be administered the treatments as outlined in the interventions section.
Induction Therapy: Phesgo plus Taxane-Based ChemotherapyTaxane-based ChemotherapyParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Inavolisib plus PhesgoInavolisibParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Inavolisib plus PhesgoOptional Endocrine Therapy of Investigator's ChoiceParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Placebo plus PhesgoPhesgoParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Placebo plus PhesgoPlaceboParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Placebo plus PhesgoOptional Endocrine Therapy of Investigator's ChoiceParticipants will be administered the treatments as outlined in the interventions section.
Primary Outcome Measures
NameTimeMethod
Investigator-Assessed Progression-Free Survival (PFS)Up to approximately 40 months
Secondary Outcome Measures
NameTimeMethod
Overall Survival (OS)Up to approximately 111 months
Investigator-Assessed Objective Response Rate (ORR)Up to approximately 111 months
Investigator-Assessed Duration of Response (DOR)Up to approximately 111 months
Investigator-Assessed Clinical Benefit Rate (CBR)Up to approximately 111 months
Investigator-Assessed PFS2Up to approximately 111 months
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)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 every 6 months (up to 111 months). Each cycle is 21 days.

Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)

Percentage of Participants with Adverse EventsDay 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.
Plasma Concentration of Inavolisib at Specified TimepointsDay 1 of Cycles 1 and 4. Each cycle is 21 days.

Trial Locations

Locations (148)

Lawrence J. Ellison Institute for Transformative Medicine

🇺🇸

Los Angeles, California, United States

Dana Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Union Hospital Tongji Medical College Huazhong University of Science and Technology

🇨🇳

Wuhan City, China

Oncomedica S.A.

🇨🇴

Monteria, Colombia

The First Hospital of Jilin University

🇨🇳

Changchun City, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

🇨🇳

Hangzhou City, China

Hubei Cancer Hospital

🇨🇳

Wuhan, China

Sichuan Provincial Cancer Hospital

🇨🇳

Chengdu, China

Sichuan Provincial People's Hospital

🇨🇳

Chengdu, China

Fujian Cancer Hospital

🇨🇳

Fuzhou, China

Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy

🇨🇳

Harbin, China

Shandong Cancer Hospital

🇨🇳

Jinan, China

The First Affiliated Hospital to Henan University of Science and Technology

🇨🇳

Luoyang City, China

Guangxi Cancer Hospital of Guangxi Medical University

🇨🇳

Nanning City, China

The Second Affiliated Hospital to Nanchang University

🇨🇳

Nanchang, China

Shantou Center Hospital

🇨🇳

Shantou City, China

Tianjin Cancer Hospital; Department of Breast Oncology

🇨🇳

Tianjin, China

Institut Sainte Catherine

🇫🇷

Avignon, France

Turku Uni Central Hospital; Oncology Clinics

🇫🇮

Turku, Finland

Klinikum St. Marien; Frauenklinik

🇩🇪

Amberg, Germany

Queen Mary Hospital; Dept. of Clinical Oncology

🇭🇰

Hong Kong, Hong Kong

Tuen Mun Hospital; Clinical Oncology

🇭🇰

Hong Kong, Hong Kong

Ospedale San Giovanni Addolorata; Oncologia

🇮🇹

Roma, Lazio, Italy

Ospedale San Raffaele; Medical Oncology

🇮🇹

Milano, Lombardia, Italy

Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Hospital Civil de Guadalajara Fray Antonio Alcalde

🇲🇽

Guadalajara, Jalisco, Mexico

Hospital Zambrano Hellion TecSalud

🇲🇽

Monterrey, Nuevo LEON, Mexico

CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

🇲🇽

Mexico City, Mexico

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

🇵🇱

Gdansk, Poland

Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

🇵🇱

Gliwice, Poland

Icon Cancer Centre Farrer Park

🇸🇬

Singapore, Singapore

Hopelands Cancer Centre

🇿🇦

Hilton, South Africa

Charlotte Maxeke Academic Hospital

🇿🇦

Johannesburg, South Africa

Medical Oncology Centre of Rosebank; Oncology

🇿🇦

Johannesburg, South Africa

Limpopo Cancer Research Institute

🇿🇦

Polokwane, South Africa

Steve Biko Academic Hospital; Oncology

🇿🇦

Pretoria, South Africa

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

🇪🇸

A Coruña, LA Coruña, Spain

Chris Hani Baragwanath Clinical Trial Site

🇿🇦

Soweto, South Africa

Hospital Universitario 12 de Octubre; Servicio de Oncologia

🇪🇸

Madrid, Spain

Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

🇪🇸

Barcelona, Spain

Hospital Universitari Vall d'Hebron

🇪🇸

Barcelona, Spain

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

🇪🇸

Malaga, Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

🇪🇸

Madrid, Spain

Hospital Universitario Virgen Macarena; Servicio de Oncologia

🇪🇸

Sevilla, Spain

Hospital Ramon y Cajal; Servicio de Oncologia

🇪🇸

Madrid, Spain

National Taiwan Uni Hospital; General Surgery

🇨🇳

Taipei, Taiwan

Tri-Service General Hospital; Department of Haematology and Oncology

🇨🇳

Taipei, Taiwan

Chang Gung Memorial Hospital-Linkou; Dept of Oncology

🇨🇳

Taoyuan County, Taiwan

Dicle University Faculty of Medicine

🇹🇷

Diyarbakir, Turkey

Medical Park Seyhan Hospital; Oncology Department

🇹🇷

Seyhan, Turkey

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

🇹🇷

Sihhiye/Ankara, Turkey

Colchester General Hospital

🇬🇧

Colchester, Essex, United Kingdom

Blackpool Victoria Hospital

🇬🇧

Blackpool, United Kingdom

Churchill Hospital; Oxford Cancer and Haematology Centre

🇬🇧

Oxford, United Kingdom

Nottingham City Hospital; Oncology

🇬🇧

Nottingham, United Kingdom

Mount Vernon Hospital; Centre For Cancer Treatment

🇬🇧

Northwood, United Kingdom

Hackensack University Medical Center

🇺🇸

Hackensack, New Jersey, United States

Centro Oncologico Korben; Oncology

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Oncología de Rosario

🇦🇷

Rosario, Argentina

Kinghorn Cancer Centre; St Vincents Hospital

🇦🇺

Darlinghurst, New South Wales, Australia

Blacktown Hospital

🇦🇺

Blacktown, New South Wales, Australia

Gosford Hospital; Cancer Care Services

🇦🇺

Gosford, New South Wales, Australia

University of the Sunshine Coast

🇦🇺

Sippy Downs, Queensland, Australia

Sir Charles Gairdner Hospital; Medical Oncology

🇦🇺

Perth, Western Australia, Australia

GHdC Site Notre Dame

🇧🇪

Charleroi, Belgium

Cliniques Universitaires St-Luc

🇧🇪

Bruxelles, Belgium

Clinique Ste-Elisabeth

🇧🇪

Namur, Belgium

Hospital Araujo Jorge; Departamento de Ginecologia E Mama

🇧🇷

Goiania, GO, Brazil

Hospital do Câncer de Londrina

🇧🇷

Londrina, PR, Brazil

Hospital de Amor Amazônia

🇧🇷

Porto Velho, RO, Brazil

Santa Casa de Misericordia de Porto Alegre

🇧🇷

Porto Alegre, RS, Brazil

Hospital de Cancer de Barretos

🇧🇷

Barretos, SP, Brazil

Tom Baker Cancer Centre-Calgary

🇨🇦

Calgary, Alberta, Canada

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

🇧🇷

Sao Paulo, SP, Brazil

The Moncton Hospital

🇨🇦

Moncton, New Brunswick, Canada

Affiliated Hospital of Hebei University; Department of medical oncology

🇨🇳

Baoding, China

Hopital du Saint Sacrement

🇨🇦

Quebec City, Quebec, Canada

Beijing Cancer Hospital

🇨🇳

Beijing, China

Atrium Health

🇺🇸

Charlotte, North Carolina, United States

Disney Family Cancer Center

🇺🇸

Burbank, California, United States

Lumi Research

🇺🇸

Kingwood, Texas, United States

Kadlec Clinic Hematology and Oncology

🇺🇸

Kennewick, Washington, United States

Swedish Medical Center

🇺🇸

Seattle, Washington, United States

Marienhospital Bottrop gGmbH; Department of Gynecology and Obstetrics

🇩🇪

Bottrop, Germany

Gynonco Düsseldorf, MVZ Medical Center GmbH

🇩🇪

Düsseldorf, Germany

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

🇩🇪

München, Germany

Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

🇩🇪

Saarbruecken, Germany

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)

🇮🇳

Surat CITY, Gujarat, India

Tampere University Hospital; Dept of Oncology

🇫🇮

Tampere, Finland

Centre Hospitalier de La Cote Basque; Oncologie

🇫🇷

Bayonne, France

Frauenarztpraxis Dr. Apel, Dr. Kolpin

🇩🇪

Erfurt, Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

🇩🇪

Freiburg, Germany

Artemis Hospital

🇮🇳

Gurugram, Haryana, India

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii

🇵🇱

Bydgoszcz, Poland

Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk

🇵🇱

Warszawa, Poland

Tata Medical Center

🇮🇳

Kolkata, WEST Bengal, India

"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

🇮🇹

Verona, Veneto, Italy

Clinica De La Costa

🇨🇴

Barranquilla, Colombia

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

🇮🇹

Milano, Lombardia, Italy

A.O.U. Maggiore della Carità

🇮🇹

Novara, Piemonte, Italy

Casa di Cura La Maddalena; Oncologia Medica

🇮🇹

Palermo, Sicilia, Italy

Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny

🇵🇱

Gdynia, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

🇵🇱

Konin, Poland

Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii

🇵🇱

Koszalin, Poland

National University Hospital; National University Cancer Institute, Singapore (NCIS)

🇸🇬

Singapore, Singapore

Tan Tock Seng Hospital; Oncology

🇸🇬

Singapore, Singapore

Seoul St Mary's Hospital

🇰🇷

Seoul, Korea, Republic of

Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

🇮🇹

Milano, Lombardia, Italy

Ospedale San Gerardo; Centro Di Ricerca di Fase I ? Piano 8 ? Settore C

🇮🇹

Monza, Lombardia, Italy

Ospedale Santa Maria Annunziata; Oncologia

🇮🇹

Bagno a Ripoli, Toscana, Italy

National Cancer Center

🇰🇷

Goyang-si, Korea, Republic of

Polyclinique Bordeaux Nord Aquitaine

🇫🇷

Bordeaux, France

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

🇨🇴

Bogota, D.C., Colombia

Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

🇩🇪

Stralsund, Germany

Centro Oncológico Hematológico Roma

🇲🇽

Mexico City, Mexico CITY (federal District), Mexico

National Cancer Centre; Medical Oncology

🇸🇬

Singapore, Singapore

Gazi University Medical Faculty

🇹🇷

Ankara, Turkey

Medstar Research Institute

🇺🇸

Hyattsville, Maryland, United States

Georgetown Uni Hospital; 4-N Main Hospital

🇺🇸

Washington, District of Columbia, United States

Medipol Mega Üniversite Hastanesi Göztepe

🇹🇷

Istanbul, Turkey

Hospital Provincial del Centenario

🇦🇷

Rosario, Argentina

Hospital Sao Rafael - HSR

🇧🇷

Salvador, BA, Brazil

Hospital do Cancer de Pernambuco - HCP

🇧🇷

Recife, PE, Brazil

Gangnam Severance Hospital

🇰🇷

Seoul, Korea, Republic of

OncoMed; Supportive Care

🇲🇽

Ciudad de México, Mexico CITY (federal District), Mexico

Jessa Zkh (Campus Virga Jesse)

🇧🇪

Hasselt, Belgium

Crio - Centro Regional Integrado de Oncologia

🇧🇷

Fortaleza, CE, Brazil

Hospital Sao Lucas - PUCRS

🇧🇷

Porto Alegre, RS, Brazil

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

🇹🇷

Bakirkoy / Istanbul, Turkey

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

🇦🇷

San Juan, Argentina

Hôpital du Sacré-Coeur de Montreal

🇨🇦

Montreal, Quebec, Canada

Banner Health MD Anderson AZ

🇺🇸

Gilbert, Arizona, United States

Monash Health

🇦🇺

Clayton, Victoria, Australia

Eastern Health - General Hospital

🇨🇦

St. John's, Newfoundland and Labrador, Canada

Instituto do Cancer do Estado de Sao Paulo - ICESP

🇧🇷

Sao Paulo, SP, Brazil

Fundación CENIT para la Investigación en Neurociencias

🇦🇷

Buenos Aires, Argentina

Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Allan Blair Cancer Center

🇨🇦

Regina, Saskatchewan, Canada

Zhejiang Cancer Hospital; Breast Surgery

🇨🇳

Hangzhou City, China

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Hightower Clinical

🇺🇸

Oklahoma City, Oklahoma, United States

I.R.S.T Srl IRCCS; Oncologia Medica

🇮🇹

Meldola, Emilia-Romagna, Italy

Clínica Viedma

🇦🇷

Viedma Rio Negro, Argentina

Renown Regional Medical Center

🇺🇸

Reno, Nevada, United States

Centre Hospitalier de l'Université de Montréal (CHUM)

🇨🇦

Montreal, Quebec, Canada

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