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
Recruiting · NCT05894239 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 12 US states.
- 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
- Sakarya Training and Research Hospital - Adapazarı, Turkey (Türkiye)
- Nagoya City University Hospital - Aichi, Japan
- Klinikum St. Marien - Amberg, Germany
- King Hussein Cancer Center - Amman, Jordan
- Institut Jules Bordet - Anderlecht, Belgium
- Gulhane Training and Research Hospital - Ankara, Turkey (Türkiye)
- Gazi University Medical Faculty - Ankara, Turkey (Türkiye)
- Abderrahmen Mami Hospital - Aryanah, Tunisia
- CHIREC - Auderghem, Belgium
- Institut Sainte Catherine - Avignon, France
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji - Bakirkoy / Istanbul, Turkey (Türkiye)
- Affiliated Hospital of Hebei University - Baoding, China
- Hospital Universitari Dexeus - Grupo Quironsalud - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Clinica De La Costa - Barranquilla, Colombia
- Centre Hospitalier de La Cote Basque - Bayonne, France
- Beijing Cancer Hospital - Beijing, China
- Belfast City Hospital - Belfast, United Kingdom
- HELIOS Klinikum Berlin-Buch - Berlin, Germany
- Blackpool Victoria Hospital - Blackpool, United Kingdom
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo - Bogota, D.C., Colombia
- Polyclinique Bordeaux Nord Aquitaine - Bordeaux, France
- Marienhospital Bottrop gGmbH - Bottrop, Germany
- CHU Brugmann (Victor Horta) - Brussels, Belgium
- Cliniques Universitaires St-Luc - Brussels, Belgium
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka - Bydgoszcz, Poland
- The First Hospital of Jilin University - Changchun, China
- GHdC Site Les Viviers - Charleroi, Belgium
- Sichuan Provincial Cancer Hospital - Chengdu, China
- Sichuan Provincial People's Hospital - Chengdu, China
- Chiba Cancer Center - Chiba, Japan
- Centro Oncologico Korben - Ciudad Autonoma Buenos Aires, Argentina
- Colchester General Hospital - Colchester, Essex, United Kingdom
- Centre Georges Francois Leclerc - Dijon, France
- Dicle University Faculty of Medicine - Diyarbakır, Turkey (Türkiye)
- 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
- Fujian Cancer Hospital - Fuzhou, China
Showing 60 of 192 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →