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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-05-01

No results posted yet for this 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).

Conditions

Interventions

DRUG

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.

DRUG

Phesgo

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

DRUG

Placebo

Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.

DRUG

Taxane-based Chemotherapy

During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2026-12-31
Completion
2032-12-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Finland
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Jordan
  • Kenya
  • Mexico
  • Oman
  • Poland
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Tunisia
  • Turkey (Türkiye)
  • Uganda
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894239 on ClinicalTrials.gov