ClinicalTrials.gov record
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
ClinicalTrials.gov ID: NCT01610284
Public ClinicalTrials.gov record NCT01610284. 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 BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Study identification
- NCT ID
- NCT01610284
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 1,147 participants
Conditions and interventions
Conditions
Not listed
Interventions
Not listed
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
- Aug 6, 2012
- Primary completion
- Apr 28, 2015
- Completion
- Apr 18, 2019
- Last update posted
- Aug 24, 2020
2012 – 2019
United States locations
- U.S. sites
- 61
- U.S. states
- 28
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2) | Mobile | Alabama | 36688 | — |
| Arizona Oncology Associates Dept of Oncology | Phoenix | Arizona | — | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Shapiro and Stafford and Yee and Polanski Study Coordinator | Arcadia | California | 91007 | — |
| Cancer Care Associates Dept.ofCancerCareAssoc. | Fresno | California | 93720 | — |
| St. Jude Heritage Medical Group Virginia Crosson Cancer Center | Fullerton | California | 92835 | — |
| University of California San Diego - Moores Cancer Center UCSD 3 | La Jolla | California | 92093-0658 | — |
| Los Angeles Hematology/Oncology Medical Group LA Cancer Network | Los Angeles | California | 90017 | — |
| USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3) | Los Angeles | California | 90053 | — |
| University of California at Los Angeles Dept. of UCLA | Los Angeles | California | 90095 | — |
| Ventura County Hematology and Oncology PMK Medical Group | Oxnard | California | 93030 | — |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | — |
| Santa Barbara Hematolgy Oncology Medical Group | Santa Barbara | California | 93105 | — |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | — |
| St Joseph Heritage Healthcare Dept. of RRMG (4) | Santa Rosa | California | 94503 | — |
| Granada Hills Cancer Center | Valencia | California | 91355 | — |
| Kaiser Permanente Northwest Kaiser | Denver | Colorado | — | — |
| Rocky Mountain Cancer Centers RMCC | Greenwood Village | Colorado | — | — |
| Memorial Regional Cancer Center MRCC | Hollywood | Florida | 33021 | — |
| Cancer Specialists of North Florida SC - F2302 | Jacksonville | Florida | 32258 | — |
| University of Miami Univ Miami 2 | Miami | Florida | 33136 | — |
| MD Anderson Cancer Center - Orlando MD Orlando | Orlando | Florida | 32806 | — |
| Georgia Cancer Specialists SC | Decatur | Georgia | 30033 | — |
| North Shore University Health System | Evanston | Illinois | 60201 | — |
| Cadence Health | Geneva | Illinois | 60134 | — |
| Cancer Care and Hematology Specialists of Chicagoland Niles | Multiple Locations | Illinois | — | — |
| Cancer Center of Kansas CCK | Wichita | Kansas | 67214-3728 | — |
| Mercy Medical Center Mercy Medical SC | Baltimore | Maryland | 21202 | — |
| Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins | Baltimore | Maryland | 21231 | — |
| Frederick Memorial Hospital Fred. Mem. Hosp. | Frederick | Maryland | 21701 | — |
| Maryland Oncology Hematology, P.A. SC | Rockville | Maryland | 20850 | — |
| Massachusetts General Hospital SC | Boston | Massachusetts | 02114 | — |
| West Michigan Cancer Center Dept of Oncology | Kalamazoo | Michigan | 49007 | — |
| Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint | Tupelo | Mississippi | 38801 | — |
| Washington University School of Medicine Regulatory | St Louis | Missouri | 63110 | — |
| Hackensack Meridian Health | Brick | New Jersey | 08724 | — |
| The Valley Hospital / Luckow Pavillion | Paramus | New Jersey | 07652 | — |
| Clinical Research Alliance SC-2 | Lake Success | New York | 11042 | — |
| Memorial Sloan Kettering Dept Onc | New York | New York | 10017 | — |
| University of Rochester Medical Center Univ Rochester | Rochester | New York | 14642 | — |
| Levine Cancer Institute Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Case Western Reserve SC | Cleveland | Ohio | 44106-5000 | — |
| Northwest Cancer Specialists Portland Loc | Portland | Oregon | 97210 | — |
| St. Luke's Hospital and Health Network St Luke's (2) | Bethlehem | Pennsylvania | 18015 | — |
| Charleston Hematology Oncology Association PA | Charleston | South Carolina | 29414 | — |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37909 | — |
| Vanderbilt University Medical Center Vanderbilt - Thompson Ln | Nashville | Tennessee | 37232 | — |
| Texas Oncology P A Midtown | Dallas | Texas | 75251 | — |
| Texas Oncology P A TX Onc - Bedford | Dallas | Texas | 75251 | — |
| Texas Oncology P A TX Onc - Med City Dallas | Dallas | Texas | 75251 | — |
| Texas Oncology P A TX Onc - Southwest | Dallas | Texas | 75251 | — |
| Oncology Consultants Oncology Consultants, P.A. | Houston | Texas | 77024 | — |
| Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development | San Antonio | Texas | 78229 | — |
| Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City | Utah | 84106 | — |
| Oncology Hematology Associates of Southeast Virginia Salem VA Branch | Roanoke | Virginia | 24014 | — |
| Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc | Kennewick | Washington | 99336 | — |
| West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology | Morgantown | West Virginia | 26506 | — |
| Cancer TEAM Bellin Health Belin Health | Green Bay | Wisconsin | 54313 | — |
| Dean Health System Dean Hematology Oncology | Madison | Wisconsin | 53717 | — |
| University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3 | Madison | Wisconsin | 53792-6164 | — |
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 109 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01610284, 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 Aug 24, 2020 · Synced May 18, 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 NCT01610284 live on ClinicalTrials.gov.