Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.
Study identification
- NCT ID
- NCT01923168
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 340 participants
Conditions and interventions
Conditions
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 11, 2014 (Actual)
- Primary completion
- Jul 7, 2017 (Actual)
- Completion
- Jul 8, 2017 (Actual)
- Last update posted
- Sep 14, 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 14, 2018 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01923168 live on ClinicalTrials.gov.