# 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

> **NCT06790693** · PHASE3 · RECRUITING · sponsor: **Hoffmann-La Roche** · enrollment: 450 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Inavolisib
- **DRUG:** Placebo
- **DRUG:** CDK4/6i
- **DRUG:** Letrozole

## Key facts

- **NCT ID:** NCT06790693
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-04-09
- **Primary completion:** 2032-05-30
- **Final completion:** 2032-05-30
- **Target enrollment:** 450 (ESTIMATED)
- **Last updated:** 2026-05-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06790693

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06790693, "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". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT06790693. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*