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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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 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.

NCT01572727•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed Description

Based on the efficacy results at the time of the interim analyses, the DMC recommended stopping the study at Phase II during the interim as it met the protocol pre-specified futility criteria. Consequently, the Phase III portion of the study was not conducted.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Breast cancer that is locally advanced or metastatic
•HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)
•A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
•Adequate bone marrow and organ function
•Measurable or non-measurable disease

Exclusion Criteria

•Prior chemotherapy for locally advanced or metastatic disease
•Previous treatment with PI3K or AKT inhibitors
•Patient has symptomatic CNS metastases
•Concurrent malignancy or malignancy within 3 years of study enrollment
•Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug
•Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
•Active heart (cardiac) disease as defined in the protocol
•Known hypersensitivity or contraindications to use paclitaxel
•Pregnant or nursing (lactating) woman
•Certain scores on an anxiety and depression mood questionaire given at screening
+1 more criteria

Locations (112)

Ironwood Cancer and Research Centers SC

Chandler, Arizona, United States

Arizona Oncology Associates Dept of Oncology

Phoenix, Arizona, United States

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, United States

California Cancer Care Marian Speciality

Greenbrae, California, United States

Rocky Mountain Cancer Centers RMCC Hale Pkwy

Greenwood Village, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute SC

Tampa, Florida, United States

Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

Atlanta, Georgia, United States

Northwest Georgia Oncology Center NW Georgia Onc

Marietta, Georgia, United States

University of Kansas Cancer Center Univ Kansas 2

Kansas City, Kansas, United States

Norton Healthcare, Inc.

Louisville, Kentucky, United States

Key Dates

Start Date

August 1, 2012

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

March 9, 2017

Enrollment

416

ACTUAL participants

Conditions

Breast Cancer

Interventions

Paclitaxel

DRUG

BKM120 matching placebo

DRUG

BKM120

DRUG

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer