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Clinical Trials in India / NCT05894239
Recruiting Phase 3

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

NCT05894239 · tracked via the Priya Life Science India tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2023-09-08
Last updated
2026-08-25

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

InavolisibPhesgoPlaceboTaxane-based ChemotherapyOptional Endocrine Therapy of Investigator's Choice

Inavolisib: 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: Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

Placebo: 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: 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: 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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (192)

FacilityCityRegionStatus
Banner Health MD Anderson AZ Gilbert Arizona Recruiting
Disney Family Cancer Center Burbank California Recruiting
City of Hope Corona California Recruiting
City of Hope Comprehensive Cancer Center Duarte California Recruiting
City of Hope at Irvine Lennar Irvine California Recruiting
Ellison Medical Institute Los Angeles California Recruiting
Georgetown Uni Hospital Washington D.C. District of Columbia Recruiting
Medstar Research Institute Hyattsville Maryland Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Renown Regional Medical Center Reno Nevada Withdrawn
Hackensack University Medical Center Hackensack New Jersey Withdrawn
Atrium Health Charlotte North Carolina Recruiting
Hightower Clinical Oklahoma City Oklahoma Withdrawn
Renovatio Clinical - El Paso El Paso Texas Recruiting
JPS Health Network Fort Worth Texas Recruiting
Lumi Research Kingwood Texas Withdrawn
Renovatio Clinical The Woodlands Texas Recruiting
Kadlec Clinic Hematology and Oncology Kennewick Washington Recruiting
Swedish Medical Center Seattle Washington Recruiting
Centro de Investigaciones Médicas y Desarrollo LC S.R.L Buenos Aires Ciudad Autónoma de BuenosAires Active Not Recruiting
Centro Oncologico Korben Ciudad Autonoma Buenos Aires Argentina Active Not Recruiting
Instituto de Oncología de Rosario Rosario Argentina Active Not Recruiting
Hospital Provincial del Centenario Rosario Argentina Active Not Recruiting
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica San Juan Argentina Active Not Recruiting
Clínica Viedma Viedma Rio Negro Argentina Withdrawn
Blacktown Hospital Blacktown New South Wales Withdrawn
Kinghorn Cancer Centre Darlinghurst New South Wales Withdrawn
Gosford Hospital Gosford New South Wales Withdrawn
University of the Sunshine Coast Sippy Downs Queensland Withdrawn
Monash Health Clayton Victoria Completed
Sir Charles Gairdner Hospital Perth Western Australia Completed
Institut Jules Bordet Anderlecht Belgium Withdrawn
CHIREC Auderghem Belgium Withdrawn
CHU Brugmann (Victor Horta) Brussels Belgium Withdrawn
Cliniques Universitaires St-Luc Brussels Belgium Withdrawn
GHdC Site Les Viviers Charleroi Belgium Withdrawn
CHU HELORA - Hôpital de la Louvière - Site Jolimont Haine-Saint-Paul Belgium Active Not Recruiting
Jessa Zkh (Campus Virga Jesse) Hasselt Belgium Withdrawn
Clinique Ste-Elisabeth Namur Belgium Withdrawn

+ 152 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05894239 on ClinicalTrials.gov ↗ ← All trials in India