Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
Public ClinicalTrials.gov record NCT03056755. 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
BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments
Study identification
- NCT ID
- NCT03056755
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 383 participants
Conditions and interventions
Conditions
Interventions
- Alpelisib Drug
- Fulvestrant Drug
- Goserelin Drug
- Letrozole Drug
- Leuprolide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- 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
- Aug 28, 2017
- Primary completion
- Jun 13, 2021
- Completion
- Nov 11, 2024
- Last update posted
- Jan 12, 2026
2017 – 2024
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Kaiser Permanente Medical Group | Anaheim | California | 92807 | — |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| University of Calif Irvine Med Cntr | Irvine | California | 92660 | — |
| Kaiser Permanent Southern Californi | San Diego | California | 92120 | — |
| UCSF | San Francisco | California | 94115 | — |
| Yale University Yale Cancer Center | New Haven | Connecticut | 06511 | — |
| Advent Health Cancer Institute | Orlando | Florida | 32804 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66205 | — |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Greater Baltimore Med Center Cancer Center | Baltimore | Maryland | 21204 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| Josephine Ford Cancer Center | Detroit | Michigan | 48202 | — |
| St Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87106 | — |
| Memorial Sloane Ketterin Cancer Ctr | New York | New York | 10065 | — |
| Uni Hosp of Cleveland Cancer Center | Cleveland | Ohio | 44106 | — |
| Texas Oncology | Dallas | Texas | 75246 | — |
| Cancer Care Centers of South Texas HOAST | San Antonio | Texas | 78229 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Northwest Medical Specialists | 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 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03056755, 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 Jan 12, 2026 · Synced May 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03056755 live on ClinicalTrials.gov.