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A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

NCT07405801 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-18

No results posted yet for this study

Summary

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).

Conditions

Interventions

DRUG

Inavolisib

Inavolisib will be administered as per the schedule mentioned in the protocol.

DRUG

Ribociclib

Ribociclib will be administered as per the schedule mentioned in the protocol.

DRUG

Fulvestrant

Fulvestrant will be administered as per the schedule mentioned in the protocol.

DRUG

Placebo

Placebo will be administered as per the schedule mentioned in the protocol.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-07
Primary Completion
2028-12-19
Completion
2030-02-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • France
  • Italy
  • Poland
  • South Korea
  • Spain
  • 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 NCT07405801 on ClinicalTrials.gov