A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
Public ClinicalTrials.gov record NCT01572727. 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 Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
Study identification
- NCT ID
- NCT01572727
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 416 participants
Conditions and interventions
Conditions
Interventions
- BKM120 Drug
- BKM120 matching placebo Drug
- Paclitaxel Drug
Drug
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
- Jul 31, 2012
- Primary completion
- May 31, 2015
- Completion
- May 31, 2015
- Last update posted
- Mar 8, 2017
2012 – 2015
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers SC | Chandler | Arizona | 85224 | — |
| Arizona Oncology Associates Dept of Oncology | Phoenix | Arizona | — | — |
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville | Arkansas | 72703 | — |
| California Cancer Care Marian Speciality | Greenbrae | California | 94904 | — |
| Rocky Mountain Cancer Centers RMCC Hale Pkwy | Greenwood Village | Colorado | — | — |
| H. Lee Moffitt Cancer Center & Research Institute SC | Tampa | Florida | 33612 | — |
| Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2) | Atlanta | Georgia | 30322 | — |
| Northwest Georgia Oncology Center NW Georgia Onc | Marietta | Georgia | 30060 | — |
| University of Kansas Cancer Center Univ Kansas 2 | Kansas City | Kansas | 66160 | — |
| Norton Healthcare, Inc. | Louisville | Kentucky | 40202 | — |
| Washington University School of Medicine Regulatory | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center Unv Nebraska Med Ctr (2) | Omaha | Nebraska | 68198 | — |
| University of New Mexico Cancer Research Center Dept of Univ New Mexico | Albuquerque | New Mexico | 87131 | — |
| New York Oncology Hematology, P.C. Dept. of New York Oncology. PC | Troy | New York | 12180 | — |
| Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1 | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center OUHSC 2 | Oklahoma City | Oklahoma | 73104 | — |
| Northwest Cancer Specialists Vancouver Loc | Portland | Oregon | 97210 | — |
| Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center Harry Hines | Dallas | Texas | 75390 | — |
| Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio | San Antonio | Texas | 78229 | — |
| Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA | Reston | Virginia | 20190 | — |
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 91 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01572727, 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 Mar 8, 2017 · Synced May 6, 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 NCT01572727 live on ClinicalTrials.gov.