Inavolisib + Ribociclib + Fulvestrant for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for men and women with advanced breast cancer that can't be treated with surgery or radiation. They should have hormone receptor-positive tumors, no prior systemic therapy for metastatic cancer, and must have worsened during or after endocrine-based treatment. Participants need confirmed chromosome 8p loss without PIK3CA mutation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inavolisib, ribociclib, and fulvestrant or placebo, ribociclib, and fulvestrant
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fulvestrant
- Inavolisib
- Ribociclib
Trial Overview
The study tests a combination of Inavolisib, Ribociclib, and Fulvestrant against a placebo plus Ribociclib and Fulvestrant in patients with HR+, HER2- advanced breast cancer. It aims to see if the triplet combo is effective and safe as a first-line treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive inavolisib, ribociclib and fulvestrant.
Participants will receive placebo, ribociclib and fulvestrant.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
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