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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer HR+, HER2-

Thank you

Trial Information

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


Inclusion Criteria:



- Postmenopausal women

- Breast cancer that is locally advanced or metastatic

- HER2 negative disease, and a known positive hormone receptor status (common breast
cancer classification tests)

- A tumor sample must be shipped to a central lab for identification of biomarkers
(PI3K activation status) before randomization

- Prior treatment with AIs

- Evidence of progression to the combination of mTORi and endocrine therapy given as
the last therapy prior to study entry

- Adequate bone marrow and organ function

Exclusion Criteria:

- More than 1 prior chemotherapy given for locally advanced or metastatic disease

- Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant

- Symptomatic CNS metastases

- Concurrent malignancy or malignancy within 3 years prior to start of study treatment

- Certain drugs or radiation within 2-4 weeks of enrollment

- Increasing or chronic treatment (> 5 days) with corticosteroids or another
immunosuppressive agent

- Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the
protocol

- HyperSsensitivity to fulvestrant treatment excipients

- Certain scores on an anxiety and depression mood questionnaire given at screening

- Other protocol defined criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS is defined as time from date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 8 weeks after randomization.

Outcome Time Frame:

Up to approx. 5.5 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120F2303

NCT ID:

NCT01633060

Start Date:

October 2012

Completion Date:

October 2016

Related Keywords:

  • Metastatic Breast Cancer HR+, HER2-
  • BKM120
  • fulvestrant
  • breast cancer
  • metastatic
  • locally advanced
  • AI treated
  • mTOR inhibitor
  • PI3K
  • PIK3CA
  • PTEN
  • Breast Neoplasms

Name

Location

Kaiser Permanente HawaiiHonolulu, Hawaii  96819
Northeast Georgia Cancer CareAthens, Georgia  30607
Northwest Cancer Specialists Vancouver LocationPortland, Oregon  97210
US Oncology Central MonitoringDallas, Texas  75246
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
Texas Oncology, P.A. Central Austin Cancer CenterDallas, Texas  75251
The West Clinic Dept. of the West ClinicMemphis, Tennessee  38120
Texas Oncology, P.A. Texas Oncology - SammonsDallas, Texas  75246
Compassionate Cancer Care Medical Group CCCMGFountain Valley, California  92708
Pacific Cancer CareSalinas, California  93901
Washington University School Of Medicine-Siteman Cancer Ctr SCSt. Louis, Missouri  63110
University of South Alabama / Mitchell Cancer Institute Univ South ALMobile, Alabama  36688
Cedars Sinai Medical Center Cedars 2Los Angeles, California  90048
Emory University School of Medicine/Winship Cancer Institute EmoryAtlanta, Georgia  30322
Hematology and Oncology Specialists SCMetairie, Louisiana  70006
Ochsner Clinic Foundation Ochsner 2New Orleans, Louisiana  70121
University of Maryland Medical Center Univ MarylandBaltimore, Maryland  21201
Holy Cross Hospital Holy CrossSilver Spring, Maryland  20910
University of Texas Southwestern Medical Center UT Southwestern 2Dallas, Texas  75390-8527
Mercy Medical Research Institute SCManchester, Missouri  63021
Case Western Reserve SCCleveland, Ohio  44106-5000
University of California at Los Angeles UCLA SCLos Angeles, California  90095
Edward Hospital Edward HospitalNaperville, Illinois  60540
Cancer Center of Kansas Dept.ofCancerCtr.ofKansasWichita, Kansas  67214-3728
Lsu Health Sciences Center/ Lsu School of Medicine LsuNew Orleans, Louisiana  70115
Morristown Memorial Hospital Morristown MemMorristown, New Jersey  07962
CINJ at Cooper University Hospital Dept of OncVoorhees, New Jersey  08043
Montefiore Medical Center MontefioreBronx, New York  10467
Oregon Health & Science University SC-5Portland, Oregon  97239
University of Pittsburgh Cancer Institute Dept of Magee Women's HospitalPittsburgh, Pennsylvania  15232
Avera Research Institute Avera SCSioux Falls, South Dakota  57105
Texas Oncology, P.A. Texas Oncology - Fort Worth (3Dallas, Texas  75251
Texas Tech University Health Science Center Dept of Texas TechEl Paso, Texas  79905
The Baylor College of Medicine/The Methodist Hospital MethodistHouston, Texas  77030