A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
Public ClinicalTrials.gov record NCT01633060. 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 AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).
Study identification
- NCT ID
- NCT01633060
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 432 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
- Oct 3, 2012 (Actual)
- Primary completion
- May 23, 2016 (Actual)
- Completion
- Sep 21, 2017 (Actual)
- Last update posted
- Jan 30, 2019
2012 – 2017
United States locations
- U.S. sites
- 37
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama / Mitchell Cancer Institute Univ South AL | Mobile | Alabama | 36688 | — |
| Ironwood Cancer and Research Centers SC | Chandler | Arizona | 85224 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Compassionate Cancer Care Medical Group CCCMG | Fountain Valley | California | 92708 | — |
| Los Angeles Hematology/Oncology Medical Group Onc Dept. | Los Angeles | California | 90017 | — |
| Cedars Sinai Medical Center SC-5 | Los Angeles | California | 90048 | — |
| University of California at Los Angeles UCLA SC | Los Angeles | California | 90095 | — |
| Pacific Cancer Care | Monterey | California | 93940 | — |
| Rocky Mountain Cancer Centers SC | Denver | Colorado | 80218 | — |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | — |
| Emory University School of Medicine/Winship Cancer Institute Emory | Atlanta | Georgia | 30322 | — |
| Moanalua Medical Center. Attn: Oncology Dept | Honolulu | Hawaii | 96817 | — |
| Edward Hospital Edward Hospital | Naperville | Illinois | 60540 | — |
| Crescent City Research Consortium, LLC SC | Metairie | Louisiana | 70006 | — |
| Lsu Health Sciences Center/ Lsu School of Medicine Lsu | New Orleans | Louisiana | 70115 | — |
| John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2 | New Orleans | Louisiana | 70121 | — |
| LSU Health Sciences Center Feist-Weiller Cancer Center | New Orleans | Louisiana | 70122-2822 | — |
| University of Maryland Medical Center Univ Maryland | Baltimore | Maryland | 21201 | — |
| Mercy Medical Research Institute SC | Manchester | Missouri | 63021 | — |
| Morristown Memorial Hospital Morristown Mem | Morristown | New Jersey | 07962 | — |
| CINJ at Cooper University Hospital Dept of Onc | Voorhees Township | New Jersey | 08043 | — |
| Clinical Research Alliance BKM120F2303 | Lake Success | New York | 11042 | — |
| Clinical Research Alliance | Lake Success | New York | 11042 | — |
| Montefiore Medical Center Montefiore | The Bronx | New York | 10467 | — |
| Northwest Cancer Specialists Compass Oncology -BKM | Portland | Oregon | 97210 | — |
| Oregon Health and Science University SC-5 | Portland | Oregon | 97239 | — |
| University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital | Pittsburgh | Pennsylvania | 15232 | — |
| The West Clinic Dept. of the West Clinic | Memphis | Tennessee | 38120 | — |
| Texas Oncology PA Dallas Presbyterian Hospital SC | Dallas | Texas | 75231 | — |
| Texas Oncology Texas Oncology - Sammons | Dallas | Texas | 75246 | — |
| Texas Oncology P A SC-Austin | Dallas | Texas | 75251 | — |
| Texas Oncology P A Texas Oncology - Fort Worth (3 | Dallas | Texas | 75251 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Tech University Health Science Center Dept of Texas Tech | El Paso | Texas | 79905 | — |
| The Methodist Hospital Cancer Center | Houston | Texas | 77030 | — |
| US Oncology, P.A. | Tyler | Texas | 75702 | — |
| Northwest Medical 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 160 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01633060, 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 30, 2019 · Synced Oct 25, 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 public registry record, listed eligibility criteria, and available contact information for NCT01633060 live on ClinicalTrials.gov.