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
Phase 3 – large-scale trial before approval
Conditions:
Metastatic Breast Cancer
Sponsor: Hoffmann-La Roche
trial.available_in:
БГ
Overview
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 participate
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
Locations
28
Argentina (1)
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires , Ciudad Autónoma de BuenosAires
ACTIVE_NOT_RECRUITING
Australia (1)
Blacktown Hospital
Blacktown , New South Wales
Belgium (1)
Institut Jules Bordet
Anderlecht
Brazil (1)
Crio - Centro Regional Integrado de Oncologia
Fortaleza , Ceará
Canada (1)
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary , Alberta
China (1)
Affiliated Hospital of Hebei University
Baoding
Colombia (1)
Clinica De La Costa
Barranquilla
WITHDRAWN
Finland (1)
Tampere University Hospital
Tampere
ACTIVE_NOT_RECRUITING
France (1)
Institut Sainte Catherine
Avignon
Germany (1)
Klinikum St. Marien
Amberg
Hong Kong (1)
Queen Mary Hospital
Hong Kong
India (1)
Gujarat Cancer & Research Inst.
Ahmedabad , Gujarat
Italy (1)
I.R.S.T Srl IRCCS
Meldola , Emilia-Romagna
Japan (1)
Chiba Cancer Center
Chiba
Jordan (1)
King Hussein Cancer Center
Amman
Kenya (1)
University of Nairobi - Institute of Tropical and Infectious Diseases
Nairobi
Mexico (1)
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara , Jalisco
Oman (1)
Sultan Qaboos Comprehensive Cancer Care & Research Center
Muscat
Poland (1)
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz
Singapore (1)
National University Hospital
Singapore
South Africa (1)
Hopelands Cancer Centre
Hilton
South Korea (1)
National Cancer Center
Goyang-si
ACTIVE_NOT_RECRUITING
Spain (1)
Complejo Hospitalario Universitario A Coruña (CHUAC)