Last updated 22 days ago
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
230 patients around the world
Available in Colombia, Brazil, United States, Argentina
Hoffmann-La Roche
5Research sites
230Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Centro Oncológico Korben
Recruiting
StudyINAVO122
SponsorHoffmann-La Roche
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05894239
