# A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

> **NCT05894239** · PHASE3 · RECRUITING · sponsor: **Hoffmann-La Roche** · enrollment: 230 (estimated)

## Conditions studied

- Metastatic Breast Cancer

## Interventions

- **DRUG:** Inavolisib
- **DRUG:** Phesgo
- **DRUG:** Placebo
- **DRUG:** Taxane-based Chemotherapy
- **DRUG:** Optional Endocrine Therapy of Investigator's Choice

## Key facts

- **NCT ID:** NCT05894239
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-09-08
- **Primary completion:** 2026-12-31
- **Final completion:** 2032-12-28
- **Target enrollment:** 230 (ESTIMATED)
- **Last updated:** 2026-05-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05894239

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05894239, "A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT05894239. Licensed CC0.

---

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