# Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

> **NCT01610284** · PHASE3 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 1147 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Fulvestrant
- **DRUG:** BKM120
- **DRUG:** BKM120 matching placebo

## Key facts

- **NCT ID:** NCT01610284
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-08-07
- **Primary completion:** 2015-04-29
- **Final completion:** 2019-04-19
- **Target enrollment:** 1147 (ACTUAL)
- **Last updated:** 2020-08-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01610284

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01610284, "Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT01610284. Licensed CC0.

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