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A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

NCT07054190 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-27

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Conditions

Interventions

DRUG

Inavolisib

Inavolisib will be administered as per the schedule specified in the arms

DRUG

Ribociclib

Ribociclib will be administered as per the schedule specified in the arms

DRUG

Letrozole

Letrozole will be administered as per the schedule specified in the arms

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2027-07-31
Completion
2027-09-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Germany
  • South Korea
  • Spain

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 NCT07054190 on ClinicalTrials.gov