RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT05894239

Registry updated: 2026-10-16

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Description

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).

Interventions

Inavolisib (Drug)
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
Phesgo (Drug)
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Placebo (Drug)
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Taxane-based Chemotherapy (Drug)
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Optional Endocrine Therapy of Investigator's Choice (Drug)
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.

Eligibility criteria

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 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

Conditions

Metastatic Breast Cancer

Locations

Banner Health MD Anderson AZ — Gilbert, Arizona, United States
Disney Family Cancer Center — Burbank, California, United States
City of Hope — Corona, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
City of Hope at Irvine Lennar — Irvine, California, United States
Ellison Medical Institute — Los Angeles, California, United States
Georgetown Uni Hospital — Washington D.C., District of Columbia, United States
Medstar Research Institute — Hyattsville, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Henry Ford Hospital — Detroit, Michigan, United States
Renown Regional Medical Center — Reno, Nevada, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Atrium Health — Charlotte, North Carolina, United States
Hightower Clinical — Oklahoma City, Oklahoma, United States
Renovatio Clinical - El Paso — El Paso, Texas, United States
JPS Health Network — Fort Worth, Texas, United States
Lumi Research — Kingwood, Texas, United States
Renovatio Clinical — The Woodlands, Texas, United States
Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
Swedish Medical Center — Seattle, Washington, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L — Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Centro Oncologico Korben — Ciudad Autonoma Buenos Aires, Argentina
Instituto de Oncología de Rosario — Rosario, Argentina
Hospital Provincial del Centenario — Rosario, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, Argentina
Clínica Viedma — Viedma Rio Negro, Argentina
Blacktown Hospital — Blacktown, New South Wales, Australia
Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia
Gosford Hospital — Gosford, New South Wales, Australia
University of the Sunshine Coast — Sippy Downs, Queensland, Australia
Monash Health — Clayton, Victoria, Australia
Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
Institut Jules Bordet — Anderlecht, Belgium
CHIREC — Auderghem, Belgium
CHU Brugmann (Victor Horta) — Brussels, Belgium
Cliniques Universitaires St-Luc — Brussels, Belgium
GHdC Site Les Viviers — Charleroi, Belgium
CHU HELORA - Hôpital de la Louvière - Site Jolimont — Haine-Saint-Paul, Belgium
Jessa Zkh (Campus Virga Jesse) — Hasselt, Belgium
Clinique Ste-Elisabeth — Namur, Belgium
Crio - Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSR — Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge — Goiânia, Goiás, Brazil
Hospital do Câncer de Londrina — Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco, Brazil
Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor Amazônia — Porto Velho, Rondônia, Brazil
Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary — Calgary, Alberta, Canada
The Moncton Hospital — Moncton, New Brunswick, Canada
Eastern Health - General Hospital — St. John's, Newfoundland and Labrador, Canada
Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
Jewish General Hospital — Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal — Montreal, Quebec, Canada
Centre Hospitalier de l?Université de Montréal (CHUM) — Montreal, Quebec, Canada
Hopital du Saint Sacrement — Québec, Quebec, Canada
Allan Blair Cancer Center — Regina, Saskatchewan, Canada
Affiliated Hospital of Hebei University — Baoding, China
Beijing Cancer Hospital — Beijing, China
The First Hospital of Jilin University — Changchun, China
Sichuan Provincial Cancer Hospital — Chengdu, China
Sichuan Provincial People's Hospital — Chengdu, China
Fujian Cancer Hospital — Fuzhou, China
Zhejiang Cancer Hospital — Hangzhou, China
Harbin Medical University Tumor Hospital — Harbin, China
Shandong Cancer Hospital — Jinan, China
The First Affiliated Hospital to Henan University of Science and Technology — Luoyang, China
The Second Affiliated Hospital to Nanchang University — Nanchang, China
Guangxi Cancer Hospital of Guangxi Medical University — Nanning, China
Shantou Center Hospital — Shantou, China
Tianjin Cancer Hospital — Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
Hubei Cancer Hospital — Wuhan, China
Clinica De La Costa — Barranquilla, Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo — Bogota, D.C., Colombia
Oncomedica S.A. — Montería, Colombia
Sociedad de Oncología y hematología del Cesar Ltda — Valledupar, Colombia
Tampere University Hospital — Tampere, Finland
Turku Uni Central Hospital — Turku, Finland
Institut Sainte Catherine — Avignon, France
Centre Hospitalier de La Cote Basque — Bayonne, France
Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France
Centre Georges Francois Leclerc — Dijon, France
Centre Oscar Lambret — Lille, France
Klinikum St. Marien — Amberg, Germany
HELIOS Klinikum Berlin-Buch — Berlin, Germany
Marienhospital Bottrop gGmbH — Bottrop, Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH — Düsseldorf, Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin — Erfurt, Germany
Universitätsklinikum Erlangen — Erlangen, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR — Freiburg im Breisgau, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt — München, Germany
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren — Münster, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum — Saarbrücken, Germany
Gynäkologie Kompetenzzentrum — Stralsund, Germany
Universitätsfrauenklinik Ulm — Ulm, Germany
Queen Mary Hospital — Hong Kong, Hong Kong
Tuen Mun Hospital — Hong Kong, Hong Kong
Gujarat Cancer & Research Inst. — Ahmedabad, Gujarat, India
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd) — Surat, Gujarat, India
Artemis Hospital — Gurugram, Haryana, India
Sir H. N. Reliance Foundation Hospital and Research Centre — Mumbai, Maharashtra, India
National Cancer Institute — Nagpur, Maharashtra, India
Max Super Speciality Hospital — NEW Delhi Delhi, National Capital Territory of Delhi, India
Tata Medical Center — Kolkata, West Bengal, India
I.R.S.T Srl IRCCS — Meldola, Emilia-Romagna, Italy
Ospedale San Giovanni Addolorata — Rome, Lazio, Italy
Ospedale San Raffaele — Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int) — Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO) — Milan, Lombardy, Italy
Ospedale San Gerardo — Monza, Lombardy, Italy
A.O.U. Maggiore della Carità — Novara, Piedmont, Italy
Casa di Cura La Maddalena — Palermo, Sicily, Italy
Ospedale Santa Maria Annunziata — Bagno a Ripoli, Tuscany, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento" — Verona, Veneto, Italy
Nagoya City University Hospital — Aichi, Japan
Chiba Cancer Center — Chiba, Japan
Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Japan
Sagara Hospital — Kagoshima, Japan
Tokai University Hospital — Kanagawa, Japan
Kyoto University Hospital — Kyoto, Japan
National Hospital Organization Shikoku Cancer Center — Matsuyama, Japan
Saitama Medical University International Medical Center — Saitama, Japan
The Cancer Institute Hospital of JFCR — Tokyo, Japan
King Hussein Cancer Center — Amman, Jordan
University of Nairobi - Institute of Tropical and Infectious Diseases — Nairobi, Kenya
Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
OncoMed — Mexico City, Mexico CITY (federal District), Mexico
Centro Oncológico Hematológico Roma — Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario — Monterrey, Nuevo León, Mexico
CENEIT Oncologicos — Mexico City, Mexico
Sultan Qaboos Comprehensive Cancer Care & Research Center — Muscat, Oman
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka — Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne — Gda?sk, Poland
Szpital Morski im.PCK — Gdynia, Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach — Gliwice, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski — Konin, Poland
Szpital Wojewódzki im. Miko?aja Kopernika — Koszalin, Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie — Późna, Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie — Warsaw, Poland
National University Hospital — Singapore, Singapore
National Cancer Centre — Singapore, Singapore
Icon Cancer Centre Farrer Park — Singapore, Singapore
Tan Tock Seng Hospital — Singapore, Singapore
Hopelands Cancer Centre — Hilton, South Africa
Charlotte Maxeke Academic Hospital — Johannesburg, South Africa
Medical Oncology Centre of Rosebank — Johannesburg, South Africa
Limpopo Cancer Research Institute — Polokwane, South Africa
Steve Biko Academic Hospital — Pretoria, South Africa
Chris Hani Baragwanath Clinical Trial Site — Soweto, South Africa
National Cancer Center — Goyang-si, 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
Complejo Hospitalario Universitario A Coruña (CHUAC) — A Coruña, LA Coruna, Spain
Hospital Universitari Dexeus - Grupo Quironsalud — Barcelona, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital General Universitario Gregorio Marañon — Madrid, Spain
Hospital Ramon y Cajal — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria — Málaga, Spain
Hospital Universitario Virgen Macarena — Seville, Spain
National Taiwan Uni Hospital — Taipei, Taiwan
Tri-Service General Hospital — Taipei, Taiwan
Chang Gung Memorial Hospital-Linkou — Taoyuan County, Taiwan
Abderrahmen Mami Hospital — Aryanah, Tunisia
Taher Maamouri Hospital — Nabeul, Tunisia
Habib Bourguiba Hospital — Sfax, Tunisia
Farhat Hached Hospital — Sousse, Tunisia
Institut Salah Azeiz — Tunis, Tunisia
Sakarya Training and Research Hospital — Adapazarı, Turkey (Türkiye)
Gulhane Training and Research Hospital — Ankara, Turkey (Türkiye)
Gazi University Medical Faculty — Ankara, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji — Bakirkoy / Istanbul, Turkey (Türkiye)
Dicle University Faculty of Medicine — Diyarbakır, Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe — Istanbul, Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital — Izmir, Turkey (Türkiye)
Medical Park Seyhan Hospital — Seyhan, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital — Sihhiye/Ankara, Turkey (Türkiye)
Uganda Cancer Institute — Kampala, Uganda
Belfast City Hospital — Belfast, United Kingdom
Blackpool Victoria Hospital — Blackpool, United Kingdom
Colchester General Hospital — Colchester, Essex, United Kingdom
Mount Vernon Hospital — Northwood, United Kingdom
Nottingham City Hospital — Nottingham, United Kingdom
Churchill Hospital — Oxford, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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