# A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

> **NCT05646862** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Hoffmann-La Roche** · enrollment: 420 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Inavolisib
- **DRUG:** Fulvestrant
- **DRUG:** Alpelisib
- **DRUG:** Bupropion
- **DRUG:** Omeprazole
- **DRUG:** Midazolam

## Key facts

- **NCT ID:** NCT05646862
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-06-07
- **Primary completion:** 2026-11-13
- **Final completion:** 2029-03-30
- **Target enrollment:** 420 (ESTIMATED)
- **Last updated:** 2026-05-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05646862

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05646862, "A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy". Retrieved via AI Analytics 2026-06-22 from https://api.ai-analytics.org/clinical/NCT05646862. Licensed CC0.

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