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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01610284
Registration number
NCT01610284
Ethics application status
Date submitted
11/05/2012
Date registered
4/06/2012
Date last updated
25/08/2020
Titles & IDs
Public title
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
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Scientific 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
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Secondary ID [1]
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2011-005524-17
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Secondary ID [2]
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CBKM120F2302
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Universal Trial Number (UTN)
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Trial acronym
BELLE-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fulvestrant
Treatment: Drugs - BKM120
Treatment: Drugs - BKM120 matching placebo
Experimental: BKM120 100mg + Fulvestrant - BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
Placebo Comparator: Placebo + Fulvestrant - BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Treatment: Drugs: Fulvestrant
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
Treatment: Drugs: BKM120
BKM120 100 mg once daily
Treatment: Drugs: BKM120 matching placebo
BKM120 matching placebo, once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
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Assessment method [1]
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Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.
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Timepoint [1]
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Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to approximately 4 years
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Secondary outcome [1]
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Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
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Assessment method [1]
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Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up for the duration of the study and for an expected average of every 3 months after end of treatment.
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Timepoint [1]
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Every 3 months following end of treatment visit, assessed for approximately 5 years
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Secondary outcome [2]
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Overall Response Rate (ORR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
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Assessment method [2]
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Overall Response Rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (< 10 mm short axis)); Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Only descriptive analysis performed.
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Timepoint [2]
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From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 5 years
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Secondary outcome [3]
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Clinical Benefit Rate (CBR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
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Assessment method [3]
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Clinical Benefit Rate (CBR) is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population. Only descriptive analysis performed.
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Timepoint [3]
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From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 5 years
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Secondary outcome [4]
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Number of Participants With On-Treatments Adverse Events, Serious Adverse Events and Deaths
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Assessment method [4]
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Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths. Only descriptive analysis performed.
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Timepoint [4]
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From first dose of study treatment to 30 days after last dose of study treatment, assessed for approximately 5 years
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Secondary outcome [5]
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Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 2 Day 1
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Assessment method [5]
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Plasma samples were collected from the first 200 BKM120-treated patients on Cycle 2 Day 1 (at pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h and 24h [before Cycle 2 Day 2 dose] post-dose). Each cycle is 28 days. Only descriptive analysis performed.
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Timepoint [5]
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Cycle2 Day1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose). Each cycle is 28 days.
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Secondary outcome [6]
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Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)
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Assessment method [6]
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Pre-dose samples were collected for trough concentrations at Cycle 2 Day 1, Cycle 2 Day 15 and Cycle 3 Day 1. Each cycle is 28 days. Only descriptive analysis performed.
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Timepoint [6]
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Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1. Each cycle is 28 days.
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Secondary outcome [7]
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Median Time to Definitive Deterioration of the ECOG Performance Status - Full Analysis Set (FAS)
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Assessment method [7]
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Time to definitive deterioration of the ECOG PS was defined as the time between the date of randomization and the date of the assessment at which definitive deterioration was seen. Only descriptive analysis performed.
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Timepoint [7]
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Up to approx 27 months
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Secondary outcome [8]
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Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30
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Assessment method [8]
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The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL. Patients were assessed up to approx. 8.3 months. Only descriptive analysis performed.
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Timepoint [8]
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Cycle 1 day 1, cycle 1 day 15, 6 weeks after randomisation and then every 8 weeks until end of treatment
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Eligibility
Key inclusion criteria
Key
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/04/2019
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Sample size
Target
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Accrual to date
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Final
1147
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Sydney
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Novartis Investigative Site - Woollongong
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Novartis Investigative Site - South Brisbane
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Novartis Investigative Site - Clayton
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Novartis Investigative Site - Murdoch
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Recruitment hospital [7]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2060 - Sydney
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Recruitment postcode(s) [2]
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2500 - Woollongong
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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Greece
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State/province [100]
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Athens
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Country [101]
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Greece
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State/province [101]
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Heraklion Crete
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Country [102]
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Greece
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State/province [102]
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Patras
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Country [103]
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Hungary
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State/province [103]
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Budapest
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Country [104]
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Hungary
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State/province [104]
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Debrecen
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Country [105]
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Hungary
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State/province [105]
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Miskolc
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Country [106]
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Hungary
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Szolnok
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Country [107]
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Israel
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Haifa
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Country [108]
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Israel
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Jerusalem
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Country [109]
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Israel
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Petach Tikva
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Country [110]
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Israel
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Ramat Gan
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Country [111]
0
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Israel
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State/province [111]
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Tel Aviv
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Country [112]
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Italy
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State/province [112]
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CN
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Country [113]
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Italy
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State/province [113]
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CR
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Country [114]
0
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Italy
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State/province [114]
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CZ
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Country [115]
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Italy
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State/province [115]
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FC
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Country [116]
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Italy
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State/province [116]
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FI
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Country [117]
0
0
Italy
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State/province [117]
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LU
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Country [118]
0
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Italy
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State/province [118]
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MC
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Country [119]
0
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Italy
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State/province [119]
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MI
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Country [120]
0
0
Italy
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State/province [120]
0
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PI
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Country [121]
0
0
Italy
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State/province [121]
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PN
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Country [122]
0
0
Italy
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State/province [122]
0
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RM
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Country [123]
0
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Italy
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RN
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Country [124]
0
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Italy
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State/province [124]
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TO
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Country [125]
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Italy
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0
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VE
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Country [126]
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Italy
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State/province [126]
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Bologna
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Country [127]
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Italy
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Napoli
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Country [128]
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Japan
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Aichi
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Country [129]
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Japan
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Chiba
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Country [130]
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Japan
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Fukuoka
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Country [131]
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Japan
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Gunma
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Country [132]
0
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Japan
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State/province [132]
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Hokkaido
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Country [133]
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Japan
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Kanagawa
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Country [134]
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Japan
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State/province [134]
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Kumamoto
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Country [135]
0
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Japan
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Kyoto
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Country [136]
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Japan
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Osaka
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Country [137]
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Japan
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State/province [137]
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Tokyo
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Country [138]
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Korea, Republic of
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State/province [138]
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Gyeonggi-do
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Country [139]
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Korea, Republic of
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State/province [139]
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Seocho Gu
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Country [140]
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Korea, Republic of
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State/province [140]
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Seoul
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Country [141]
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0
Netherlands
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State/province [141]
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Nijmegen
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Country [142]
0
0
Peru
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State/province [142]
0
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Lima
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Country [143]
0
0
Poland
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State/province [143]
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Kraków
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Country [144]
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Poland
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State/province [144]
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Olsztyn
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Country [145]
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0
Poland
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State/province [145]
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Warszawa
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Country [146]
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0
Russian Federation
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State/province [146]
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Moscow
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Country [147]
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Russian Federation
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State/province [147]
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Nizhniy Novgorod
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Country [148]
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Russian Federation
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State/province [148]
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St Petersburg
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Country [149]
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Russian Federation
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State/province [149]
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St- Petersburg
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Country [150]
0
0
Singapore
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State/province [150]
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Singapore
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Country [151]
0
0
Slovakia
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State/province [151]
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Slovak Republic
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Country [152]
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Slovakia
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State/province [152]
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Kosice
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Country [153]
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0
South Africa
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State/province [153]
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0
Johannesburg
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Country [154]
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0
South Africa
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State/province [154]
0
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Parktown
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Country [155]
0
0
Spain
Query!
State/province [155]
0
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Alicante
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Country [156]
0
0
Spain
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State/province [156]
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0
Andalucia
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Country [157]
0
0
Spain
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State/province [157]
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0
Asturias
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Country [158]
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Spain
Query!
State/province [158]
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Castilla La Mancha
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Country [159]
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Spain
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State/province [159]
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Catalunya
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Country [160]
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0
Spain
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State/province [160]
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Cataluña
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Country [161]
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Spain
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State/province [161]
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Comunidad Valenciana
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Country [162]
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Spain
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State/province [162]
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0
Las Palmas De Gran Canaria
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Country [163]
0
0
Spain
Query!
State/province [163]
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Madrid
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Country [164]
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0
Spain
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State/province [164]
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Murcia
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Country [165]
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0
Spain
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State/province [165]
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Barcelona
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Country [166]
0
0
Spain
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State/province [166]
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0
Zaragoza
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Country [167]
0
0
Switzerland
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State/province [167]
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Bellinzona
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Country [168]
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0
Switzerland
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State/province [168]
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Genève
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Country [169]
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Switzerland
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State/province [169]
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0
Zuerich
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Country [170]
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0
Taiwan
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State/province [170]
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Kaohsiung
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Country [171]
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0
Taiwan
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State/province [171]
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Taichung
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Country [172]
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Taiwan
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State/province [172]
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Taipei
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Country [173]
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Thailand
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State/province [173]
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Bangkok
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Country [174]
0
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United Kingdom
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State/province [174]
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Cornwall
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Country [175]
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United Kingdom
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State/province [175]
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Bournemouth
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Country [176]
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United Kingdom
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State/province [176]
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Derby
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Country [177]
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United Kingdom
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State/province [177]
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Leicester
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Country [178]
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United Kingdom
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State/province [178]
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Liverpool
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Country [179]
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United Kingdom
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London
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Country [180]
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United Kingdom
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Manchester
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Country [181]
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United Kingdom
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State/province [181]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study
to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus
fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive
(HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally
advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase
inhibitor (AI) treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01610284
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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0
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Phone
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01610284
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