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Completed Phase 2 Interventional Results available

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

ClinicalTrials.gov ID: NCT01923168

Public ClinicalTrials.gov record NCT01923168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 16, 2026, 9:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer

Study identification

NCT ID
NCT01923168
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
340 participants

Conditions and interventions

Conditions

Interventions

  • Placebo Drug
  • alpelisib Drug
  • buparlisib Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 10, 2014
Primary completion
Jul 6, 2017
Completion
Jul 7, 2017
Last update posted
Sep 13, 2018

2014 – 2017

United States locations

U.S. sites
23
U.S. states
14
U.S. cities
19
Facility City State ZIP Site status
University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI Birmingham Alabama 35294-0006
Highlands Oncology Group Fayetteville Arkansas 72703
Los Angeles Hematology/Oncology Medical Group Onc Dept. Los Angeles California 90017
University of California at Los Angeles UCLA SC Los Angeles California 90095
University of California San Francisco BYL719A2201 - SC San Francisco California 94115
Emory University School of Medicine/Winship Cancer Institute SC Atlanta Georgia 30322
Mercy Medical Center Medical Oncology & Hematology Baltimore Maryland 21202
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Johns Hopkins Med. BYL719A2201 Baltimore Maryland 21231
Dana Farber Cancer Institute BYL719A2201 Boston Massachusetts 02215
Mayo Clinic - Rochester BYL719A2201 - SC Rochester Minnesota 55905
Cancer Institute of New Jersey New Brunswick New Jersey 08901
Duke University Medical Center Duke University Medical Center Durham North Carolina 27710
Northwest Cancer Specialists Vancouver Loc Portland Oregon 97210
Vanderbilt Ingram Cancer Center Vanderbilt Health 100 Oaks Nashville Tennessee 37203
Texas Oncology, P.A. Bedford Texas 76022
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp Dallas Texas 75231
Texas Oncology Texas Oncology - Sammons Dallas Texas 75246
Texas Oncology Houston Memorial City SC Houston Texas 77024
Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2) San Antonio Texas 78229
Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(5) San Antonio Texas 78229
Virginia Oncology Associates SC Norfolk Virginia 23502
Seattle Cancer Care Alliance SC-3 Seattle Washington 98105
Northwest Medical Specialties Dept.ofNW Med. Specialties Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01923168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 13, 2018 · Synced May 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01923168 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →