Inavolisib + CDK4/6 Inhibitor + Letrozole for Breast Cancer

(INAVO123 Trial)

Recruiting at 63 trial locations

Overseen By Reference Study ID Number: WO45654 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must be taking: CDK4/6 inhibitors, Letrozole

Must not be taking: Strong CYP3A4 inhibitors, inducers

Disqualifiers: Type 1 diabetes, CNS metastases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

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's hormone receptor-positive, HER2-negative, and has a specific mutation (PIK3CA). They should have measurable disease, be in good physical condition (ECOG 0 or 1), and either be newly diagnosed or relapsed after at least two years of standard treatment without progression.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer has the specific biomarker needed for this trial.

My cancer can be measured using specific criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inavolisib plus a CDK4/6 inhibitor and letrozole or placebo plus a CDK4/6 inhibitor and letrozole

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CDK4/6i
• Inavolisib

Trial Overview The study tests the effectiveness of Inavolisib combined with a CDK4/6 inhibitor and Letrozole against a placebo plus the same CDK4/6 inhibitor and Letrozole. It aims to see if adding Inavolisib improves outcomes for patients with certain genetic features in their tumors.

How Is the Trial Designed?

Group I: Inavolisib + Letrozole + CDK4/6i Experimental Treatment 3 Interventions

Participants will receive inavolisib, letrozole and CDK4/6i.

Group II: Placebo + Letrozole + CDK4/6i Placebo Group 3 Interventions

Participants will receive placebo, letrozole and CDK4/6i.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

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