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
Launched by HOFFMANN-LA ROCHE · Jun 7, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for patients with a specific type of advanced breast cancer known as HER2-positive metastatic breast cancer. The researchers want to find out if a drug called inavolisib, when combined with Phesgo (a medication that targets HER2), is more effective and safer than a placebo (a substance with no active ingredients) combined with Phesgo. This study is focused on patients who have not received treatment for their advanced breast cancer before and have certain genetic markers in their tumors.
To be eligible for the trial, participants should be adults aged 65 to 74 with a confirmed diagnosis of HER2-positive breast cancer that has spread and cannot be surgically removed. They also need to have specific gene mutations and good overall health. During the study, participants will receive either the new treatment or a placebo along with Phesgo and will be monitored for any side effects or changes in their condition. This trial is currently recruiting participants and aims to provide valuable information about this potential new treatment option for advanced breast cancer.
Gender
ALL
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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Avignon, , France
Lille, , France
Detroit, Michigan, United States
Hackensack, New Jersey, United States
Madrid, , Spain
Bayonne, , France
Madrid, , Spain
Moncton, New Brunswick, Canada
Hong Kong, , Hong Kong
Boston, Massachusetts, United States
Oxford, , United Kingdom
Singapore, , Singapore
Nottingham, , United Kingdom
Singapore, , Singapore
Reno, Nevada, United States
Bruxelles, , Belgium
Charleroi, , Belgium
Tampere, , Finland
Turku, , Finland
Freiburg, , Germany
Singapore, , Singapore
Madrid, , Spain
Madrid, , Spain
Northwood, , United Kingdom
Nottingham, , United Kingdom
Bordeaux, , France
Montreal, Quebec, Canada
Porto Alegre, Rs, Brazil
Gosford, New South Wales, Australia
Malaga, , Spain
Perth, Western Australia, Australia
Blackpool, , United Kingdom
Blacktown, New South Wales, Australia
Northwood, , United Kingdom
Sevilla, , Spain
Hong Kong, , Hong Kong
Toronto, Ontario, Canada
Porto Alegre, Rs, Brazil
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Madrid, , Spain
Barcelona, , Spain
Johannesburg, , South Africa
Tampere, , Finland
Beijing, , China
Fuzhou, , China
Malaga, , Spain
Oxford, , United Kingdom
Monterrey, Nuevo Leon, Mexico
Seoul, , Korea, Republic Of
Milano, Lombardia, Italy
Madrid, , Spain
Seoul, , Korea, Republic Of
Sao Paulo, Sp, Brazil
Barretos, Sp, Brazil
Ankara, , Turkey
Amberg, , Germany
Hasselt, , Belgium
Montreal, Quebec, Canada
Stralsund, , Germany
Goyang Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Calgary, Alberta, Canada
Salvador, Ba, Brazil
Namur, , Belgium
Singapore, , Singapore
Rosario, , Argentina
Hong Kong, , Hong Kong
Sevilla, , Spain
Burbank, California, United States
Saarbruecken, , Germany
Bagno A Ripoli, Toscana, Italy
Beijing, Beijing, China
Gosford, New South Wales, Australia
Monterrey, Nuevo Leon, Mexico
Guadalajara, Jalisco, Mexico
Nanchang, , China
Johannesburg, , South Africa
Pretoria, , South Africa
Rosario, , Argentina
Johannesburg, , South Africa
Jinan, , China
Perth, Western Australia, Australia
Quebec City, Quebec, Canada
Chengdu, , China
Wuhan, , China
Monteria, , Colombia
Milano, Lombardia, Italy
Taipei, , Taiwan
Colchester, Essex, , United Kingdom
Nanning, , China
Bayonne, , France
Buenos Aires, , Argentina
Diyarbakir, , Turkey
Sihhiye/Ankara, , Turkey
Goiania, Go, Brazil
Milano, Lombardia, Italy
Hilton, , South Africa
Milano, Lombardia, Italy
Chengdu, , China
Porto Alegre, Rio Grande Do Sul, Brazil
Fort Worth, Texas, United States
Hong Kong, , Hong Kong
The Woodlands, Texas, United States
Clayton, Victoria, Australia
Darlinghurst, New South Wales, Australia
Changchun City, , China
Hangzhou City, , China
Konin, , Poland
Novara, Piemonte, Italy
Montreal, Quebec, Canada
Sippy Downs, Queensland, Australia
Bagno A Ripoli, Toscana, Italy
Verona, Veneto, Italy
Seattle, Washington, United States
Taipei, , Taiwan
San Juan, , Argentina
Barranquilla, , Colombia
Wuhan City, , China
Barcelona, , Spain
Fuzhou, Fujian, China
Regina, Saskatchewan, Canada
Sao Paulo, Sp, Brazil
Gurugram, Haryana, India
Meldola, Emilia Romagna, Italy
Darlinghurst, New South Wales, Australia
A Coruña, La Coruña, Spain
Hangzhou City, , China
Monza, Lombardia, Italy
Kolkata, West Bengal, India
Londrina, Pr, Brazil
Izmir, , Turkey
Recife, Pe, Brazil
Singapore, , Singapore
Taoyuan County, , Taiwan
Oklahoma City, Oklahoma, United States
Amman, , Jordan
Charlotte, North Carolina, United States
Palermo, Sicilia, Italy
Muscat, , Oman
Harbin, , China
St. John's, Newfoundland And Labrador, Canada
Ankara, , Turkey
Istanbul, , Turkey
Gdynia, , Poland
Barcelona, , Spain
Nagpur, Maharashtra, India
Luoyang, , China
Singapore, , Singapore
Polokwane, , South Africa
Baoding, , China
Taipei, , Taiwan
Bakirkoy / Istanbul, , Turkey
Bottrop, , Germany
Düsseldorf, , Germany
Erfurt, , Germany
Warszawa, , Poland
Ahmadabad City, Gujarat, India
Kingwood, Texas, United States
Ciudad Autonoma Buenos Aires, , Argentina
Gilbert, Arizona, United States
Valledupar, , Colombia
Porto Velho, Rondônia, Brazil
München, , Germany
Londrina, Paraná, Brazil
Kennewick, Washington, United States
Fortaleza, Ce, Brazil
Viedma Rio Negro, , Argentina
Seoul, , Korea, Republic Of
Los Angeles, California, United States
El Paso, Texas, United States
Bydgoszcz, , Poland
Gliwice, , Poland
Montreal, Quebec, Canada
Koszalin, , Poland
Pretoria, , South Africa
Wuhan City, , China
Bogota, D.C., , Colombia
Singapore, , Singapore
Surat City, Gujarat, India
Ciudad De México, Mexico City (Federal District), Mexico
Mexico City, , Mexico
Mexico City, Mexico City (Federal District), Mexico
Monterrey, Nuevo Leon, Mexico
Washington, District Of Columbia, United States
Hyattsville, Maryland, United States
Porto Velho, Ro, Brazil
Seyhan, , Turkey
Tianjin, , China
Shantou City, , China
Nairobi, , Kenya
Luoyang City, , China
Nairobi, , Kenya
Gdansk, , Poland
Polokwane, , South Africa
Taipei, , Taiwan
Soweto, , South Africa
Nanning City, , China
Seyhan, , Turkey
Calgary, Alberta, Canada
Amberg, , Germany
Monza, Lombardia, Italy
Bottrop, , Germany
Roma, Lazio, Italy
Los Angeles, California, United States
Madrid, , Spain
Sao Paulo, , Brazil
New Delhi Delhi, Delhi, India
Seeb, Muscat, Muscat Governate, Oman
Poznań, , Poland
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
Hangzhou City, , China
Milano, Lombardia, Italy
Mexico City, , Mexico
Muscat, , Oman
Bydgoszcz, , Poland
Salvador, Bahia, Brazil
Goiania, Goiás, Brazil
Recife, Pernambuco, Brazil
Calgary, Alberta, Canada
Baoding, , China
Gda?Sk, , Poland
Izmir, , Turkey
Sihhiye/Ankara, , Turkey
Barretos, São Paulo, Brazil
Milano, Lombardia, Italy
Washington, District Of Columbia, United States
Ciudad Autonoma Buenos Aires, , Argentina
Fortaleza, Ceará, Brazil
Sao Paulo, São Paulo, Brazil
Harbin, , China
Tianjin, , China
Turku, , Finland
Stralsund, , Germany
New Delhi Delhi, Delhi, India
Meldola, Emilia Romagna, Italy
Roma, Lazio, Italy
Palermo, Sicilia, Italy
Nairobi, , Kenya
Ciudad De México, Mexico City (Federal District), Mexico
Gdynia, , Poland
Gliwice, , Poland
Koszalin, , Poland
Pozna?, , Poland
Warszawa, , Poland
A Coruña, La Coruna, Spain
Taoyuan County, , Taiwan
Kampala, , Uganda
Charleroi, , Belgium
Ariana, , Tunisia
Sousse, , Tunisia
Tunis, , Tunisia
Sfax, , Tunisia
Nabeul, , Tunisia
Adapazar?, , Turkey
Barretos, , Brazil
Goiania, , Brazil
Londrina, , Brazil
Sao Paulo, , Brazil
Porto Velho, , Brazil
Ciudad De México, , Mexico
Fortaleza, , Brazil
Mexico City, , Mexico
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported