A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Inavolisib — DRUG
  Participants will receive oral inavolisib once daily (QD).
• Placebo — DRUG
  Participants will receive oral placebo QD.
• CDK4/6i — DRUG
  Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
• Letrozole — DRUG
  Participants will receive oral letrozole QD.

Study Details

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).

Key Dates

Start date

Apr 9, 2025

Status verified

Jun 2026

Primary completion

May 30, 2032

Completion

May 30, 2032

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Inavolisib + Letrozole + CDK4/6i
  Participants will receive inavolisib, letrozole and CDK4/6i.
• Placebo Comparator: Placebo + Letrozole + CDK4/6i
  Participants will receive placebo, letrozole and CDK4/6i.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years) ]

Central Contacts

• Reference Study ID Number: WO45654 https://forpatients.roche.com/
  888-662-6728 (U.S. Only)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (51)

Find similar trials in Phoenix, AZ

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