NCT06790693: INAVO123

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

Recruiting now Phase 3 Last updated 3 April 2026

What this trial tests

Phase 3 trial testing Inavolisib in Breast Cancer in 450 participants. Currently enrolling.

Timeline

9 April 2025

Primary endpoint
30 May 2032

30 May 2032

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	450
Start date	9 April 2025
Primary completion	30 May 2032
Estimated completion	30 May 2032
Sites	219 locations across Puerto Rico, Japan, United States, South Africa, Italy, Switzerland, Mexico, Taiwan

Drugs / interventions tested

• Inavolisib (INAVOLISIB) — full drug profile →
• Placebo
• CDK4/6i — full drug profile →
• Letrozole — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gedatolisib Combined with Palbociclib and Letrozole in Patients with No Prior Systemic Therapy for Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer.
   Wesolowski R, Rugo HS, Specht JM, Han HS, et al · · 2025 · cited 2× · PMID 40711480 · DOI 10.1158/1078-0432.ccr-25-0992
2. Expert Consensus on the Clinical Application of PI3K/AKT/mTOR Inhibitors in the Treatment of Breast Cancer (2025 Edition).
   Breast Cancer Expert Committee of the National Quality Control Center for Cancer, Expert Committee on Cancer Prevention and Treatment of the Health China Research Center, Society of Clinical Research on Oncology Medications of the China Anti‐Cancer Association, Society of Onco‐Pathology of the China Anti‐Cancer Association. · · 2025 · cited 2× · PMID 40206206 · DOI 10.1002/cai2.70008
3. Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer.
   Abbasi MS, Afzal MZ, Sarwar T, Gamlen-Steves HA. · · 2025 · cited 1× · PMID 40940886 · DOI 10.3390/cancers17172788
4. Alternate actions of CDK4/6 inhibitors beyond cell cycle blockade: unexplored roles in therapy resistance.
   Scordamaglia D, Talia M, Zicarelli A, Mondino AA, et al · · 2025 · PMID 41388212 · DOI 10.1007/s10555-025-10307-w
5. A Decade After Approval of the First CDK4/6 Inhibitor: A Look Back at Palbociclib's Journey from Discovery to Approval and What's Next in CDK Inhibition in Breast Cancer.
   Finn RS, Rugo HS, Cortes J, Loibl S, et al · · 2025 · PMID 41087648 · DOI 10.1007/s11523-025-01175-z