Overview

This trial is active, not recruiting.

Condition metastatic breast cancer hr+, her2-
Treatments fulvestrant, bkm120, bkm120 matching placebo
Phase phase 3
Target PI3K
Sponsor Novartis Pharmaceuticals
Start date October 2012
End date March 2017
Trial size 431 participants
Trial identifier NCT01633060, 2012-002571-34, CBKM120F2303

Summary

This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.

United States Maryland, New York, Oregon, Pennsylvania, and Texas
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol test.
fulvestrant
Intramuscular fulvestrant 500 mg (cycle 1 days 1 & 15 and once every cycle thereafter)
bkm120
BKM120 100 mg once daily
(Active Comparator)
BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
fulvestrant
Intramuscular fulvestrant 500 mg (cycle 1 days 1 & 15 and once every cycle thereafter)
bkm120 matching placebo
BKM120 matching placebo, once daily

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Up to approx. 5.5 months

Secondary Outcomes

Measure
Overall survival (OS)
time frame: Up to approx. 21 months
Overall response rate (ORR)
time frame: Up to approx. 5.5 months
Clinical benefit rate (CBR)
time frame: Up to approx. 5.5 months
Type, frequency and severity of adverse events
time frame: at minimum at each study visit and up to approx. 8 months
Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK)
time frame: C1D1, C1D15, C2D1,C3D1 and C4D1 (a cycle [C] = 4 weeks), D = Day
Patient reported outcome for global health status/QoL
time frame: C1D1, C2D15, C4D1, then every 8 weeks until discontinuation (a cycle [C] = 4 weeks).
Progression Free Survival (PFS) in PIK3CA mutational status
time frame: Up to approx. 5.5 months
Overall survival (OS) in PIK3CA mutational status
time frame: Up to approx. 21 months

Eligibility Criteria

Female participants at least 18 years old.

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 - Hyper sensitivity to fulvestrant treatment excipients - Certain scores on an anxiety and depression mood questionnaire given at screening - Acute viral hepatitis or history of chronic or acute HBV, HCV, HAV, HDV, HEV - Other protocol defined 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 AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Novartis.