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NCT01572727 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 416
- Enrollment target
- 20
- Study locations
NCT01572727 is a Phase 2 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 416 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT01572727, a Phase 2 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 416 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG BKM120
- DRUG BKM120 matching placebo
Study Locations (20)
Texas
- Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology - Dallas
- University of Texas Southwestern Medical Center Harry Hines - Dallas
- Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio - San Antonio
Arizona
- Ironwood Cancer and Research Centers SC - Chandler
- Arizona Oncology Associates Dept of Oncology - Phoenix
Georgia
- Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2) - Atlanta
- Northwest Georgia Oncology Center NW Georgia Onc - Marietta
Arkansas
- Highlands Oncology Group Dept of Highlands Oncology Grp - Fayetteville
California
- California Cancer Care Marian Speciality - Greenbrae
Colorado
- Rocky Mountain Cancer Centers RMCC Hale Pkwy - Greenwood Village
Florida
- H. Lee Moffitt Cancer Center & Research Institute SC - Tampa
Kansas
- University of Kansas Cancer Center Univ Kansas 2 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572727
The ClinicalTrials.gov registry entry for NCT01572727 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT01572727 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Texas, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT01572727 about?
NCT01572727 is a clinical study titled "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". This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
What is the current status of trial NCT01572727?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 416 participants. The study started on 2012-08. Estimated completion is 2015-06.
What conditions does trial NCT01572727 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01572727?
The interventions under investigation include: Paclitaxel (DRUG), BKM120 (DRUG), BKM120 matching placebo (DRUG).
Who is sponsoring clinical trial NCT01572727?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01572727 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.