# A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer

> **NCT02058381** · PHASE1 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 40 (actual)

## Conditions studied

- Pre-menopausal Breast Cancer
- PI3K Pathway Inhibition

## Interventions

- **DRUG:** alpelisib (BYL719)
- **DRUG:** buparlisib (BKM120)

## Key facts

- **NCT ID:** NCT02058381
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-05-06
- **Primary completion:** 2018-06-19
- **Final completion:** 2018-06-19
- **Target enrollment:** 40 (ACTUAL)
- **Last updated:** 2020-03-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02058381

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02058381, "A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT02058381. Licensed CC0.

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