Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
Public ClinicalTrials.gov record NCT02437318. 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 III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.
Study identification
- NCT ID
- NCT02437318
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 572 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 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
- Jul 23, 2015 (Actual)
- Primary completion
- Jun 12, 2018 (Actual)
- Completion
- Jun 9, 2023 (Actual)
- Last update posted
- Feb 13, 2025
2015 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 22
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| City of Hope National Medical Center | Duarte | California | 91010 3000 | — |
| Scripps Green Hospital | La Jolla | California | 92037 | — |
| Kaiser Permanent Southern Californi | San Diego | California | 92120 | — |
| UCSF | San Francisco | California | 94115 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists-North | St. Petersburg | Florida | 33705 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| Edward Cancer Center | Naperville | Illinois | 60540 | — |
| Fort Wayne Medical Oncology Hematology Inc | Fort Wayne | Indiana | 46815 | — |
| St Francis Health Comprehensive Cancer Center | Topeka | Kansas | 66606-169 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| Detroit Clinical Research Center | Owosso | Michigan | 48867 | — |
| St Lukes Cancer Institute | Kansas City | Missouri | 64111 | — |
| St Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| University Hospitals of Cleveland Seidman Cancer Center | Cleveland | Ohio | 44106 | — |
| Good Samaritan Regional Medical Center | Corvallis | Oregon | 97330 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | — |
| Prisma Health Upstate | Greenville | South Carolina | 29615 | — |
| Avera Cancer | Sioux Falls | South Dakota | 57105 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| Texas Oncology PA Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| El Paso Texas Oncology | El Paso | Texas | 79902 | — |
| Mays Cancer Ctr Uthsa Mdacc | San Antonio | Texas | 78229 | — |
| Texas Oncology Northeast Texas | Tyler | Texas | 75702 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | — |
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 163 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02437318, 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 Feb 13, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02437318 live on ClinicalTrials.gov.