# A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

> **NCT04060862** · PHASE1 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 20 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Ipatasertib
- **DRUG:** Placebo
- **DRUG:** Palbociclib
- **DRUG:** Fulvestrant

## Key facts

- **NCT ID:** NCT04060862
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2019-11-21
- **Primary completion:** 2023-08-29
- **Final completion:** 2023-08-29
- **Target enrollment:** 20 (ACTUAL)
- **Why stopped:** The decision to not open the Phase III portion was based on a strategic sponsor decision and not driven by any safety concerns.
- **Last updated:** 2024-11-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04060862

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04060862, "A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer". Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/clinical/NCT04060862. Licensed CC0.

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