Summary

for females ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.

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

Keywords

Breast Cancer Hormone receptor positive HER2-negative Metastatic Locally advanced PI3K Fulvestrant Refractory Aromatase inhibitor Breast Neoplasms Hormones Estradiol Aromatase Inhibitors BKM120 BKM120 and fulvestrant

Eligibility

You can join if…

Open to females ages 18 years and up

  • Locally advanced or metastatic breast cancer
  • HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
  • Postmenopausal woman
  • A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
  • Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
  • Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
  • Adequate bone marrow and organ function defined by laboratory values

You CAN'T join if...

  • Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
  • More than one prior chemotherapy line for metastatic disease
  • Symptomatic brain metastases
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease as defined in the protocol
  • Certain scores on an anxiety and depression mood questionnaires
  • Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • University of California San Diego - Moores Cancer Center UCSD 3
    La Jolla California 92093-0658 United States
  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center
    Fullerton California 92835 United States
  • Shapiro & Stafford & Yee & Polanski Study Coordinator
    Arcadia California 91007 United States
  • USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)
    Los Angeles California 90053 United States
  • Los Angeles Hematology/Oncology Medical Group LA Cancer Network
    Los Angeles California 90017 United States
  • University of California at Los Angeles Dept. of UCLA
    Los Angeles California 90095 United States
  • Granada Hills Cancer Center
    Valencia California 91355 United States
  • Ventura County Hematology and Oncology PMK Medical Group
    Oxnard California 93030 United States
  • Santa Barbara Hematolgy Oncology Medical Group
    Santa Barbara California 93105 United States
  • Central Coast Medical Oncology Corporation
    Santa Maria California 93454 United States
  • Coastal Integrative Cancer Care
    San Luis Obispo California 93401 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01610284
Phase
Phase 3
Study Type
Interventional
Last Updated
October 16, 2017