Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments bkm120 matching placebo, fulvestrant, bkm120
Phase phase 3
Target PI3K
Sponsor Novartis Pharmaceuticals
Start date August 2012
End date January 2018
Trial size 1149 participants
Trial identifier NCT01610284, 2011-005524-17, CBKM120F2302

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
BKM120 100mg given daily and fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter. Treatment will be given until disease progression or as described in the protocol
fulvestrant
Fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter
bkm120
BKM120 100mg, daily oral capsules
(Active Comparator)
BKM120 matching placebo given daily and fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter. Treatment will be given until disease progression or as described in the protocol
bkm120 matching placebo
BKM120 matching placebo, daily oral
fulvestrant
Fulvestrant 500mg given intramuscularly at cycle 1 day 1, cycle 1 day 15 and at day 1 at each cycle thereafter

Primary Outcomes

Measure
Progression free survival (PFS)
time frame: up to approx. 8.3 months

Secondary Outcomes

Measure
Overall survival (OS)
time frame: up to approx. 32 months
Overall response rate (ORR)
time frame: up to approx. 8.3 months
Clinical benefit rate (CBR)
time frame: up to approx. 8.3 months
Type, frequency and severity of adverse events
time frame: at minimum at each study visit and up to approx. 10 months
Plasma concentration of BKM120 and Fulvestrant (Pharmacokinetics)
time frame: Cycle 1 day 1, Cycle 1 day 15, cycle 2 day 1, cycle 2 day 2, cycle 2 day 15, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1 and cycle 6 day 1
Time profile of BKM120 and Fulvestrant (Pharmacokinetics)
time frame: Cycle 1 day 1, Cycle 1 day 15, cycle 2 day 1, cycle 2 day 2, cycle 2 day 15, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1 and cycle 6 day 1
Patient reported outcomes for global health status/QOL
time frame: Cycle 1 day 1, cycle 1 day 15, 6 weeks after randomisation and then every 8 weeks until end of treatment

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in September 2016.