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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/NCT01572727
Registration number
NCT01572727
Ethics application status
Date submitted
4/04/2012
Date registered
6/04/2012
Date last updated
9/03/2017
Titles & IDs
Public title
A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
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Scientific title
A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
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Secondary ID [1]
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2011-005932-24
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Secondary ID [2]
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CBKM120F2202
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Universal Trial Number (UTN)
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Trial acronym
BELLE-4
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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 - Paclitaxel
Treatment: Drugs - BKM120 matching placebo
Treatment: Drugs - BKM120
Experimental: BKM120 and paclitaxel - Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel.
Active Comparator: Placebo and paclitaxel - Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.
Treatment: Drugs: Paclitaxel
intravenous paclitaxel 80 mg/m2 per week given until progression
Treatment: Drugs: BKM120 matching placebo
Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.
Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
Treatment: Drugs: BKM120
Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
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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)Assessed by Local Investigator's Assessment (Phase ll)
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Assessment method [1]
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PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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Timepoint [1]
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Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed
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Secondary outcome [1]
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Overall Survival by Kaplan-Meier Estimate (Phase ll)
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Assessment method [1]
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Overall survival (OS) was 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 contact.
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Timepoint [1]
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every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed
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Secondary outcome [2]
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Overall Response Rate (Phase ll)
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Assessment method [2]
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Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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Timepoint [2]
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every 8 weeks after randomization Up to 3 months after end of Treatment
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Secondary outcome [3]
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Duration of Response (Phase Lll)
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Assessment method [3]
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time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease
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Timepoint [3]
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every 8 weeks after randomization Up to 3 months after end of Treatment
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Secondary outcome [4]
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Time to Response (Phase Lll)
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Assessment method [4]
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time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).
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Timepoint [4]
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every 8 weeks after randomization Up to 3 months after end of Treatment
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Secondary outcome [5]
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Clinical Benefit Rate (CBR) (Phase ll)
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Assessment method [5]
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CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator's assessment according to RECIST v1.1.
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Timepoint [5]
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every 8 weeks after randomization Up to 3 months after end of Treatment
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Secondary outcome [6]
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Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)
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Assessment method [6]
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Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days
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Timepoint [6]
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Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.
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Secondary outcome [7]
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Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)
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Assessment method [7]
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Time to definitive deterioration of the ECOG performance status from baseline
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Timepoint [7]
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every 4 weeks
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Eligibility
Key inclusion criteria
- Breast cancer that is locally advanced or metastatic
- HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast
cancer classification tests)
- A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K
activation status) before randomization
- Adequate bone marrow and organ function
- Measurable or non-measurable disease
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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
- Prior chemotherapy for locally advanced or metastatic disease
- Previous treatment with PI3K or AKT inhibitors
- Patient has symptomatic CNS metastases
- Concurrent malignancy or malignancy within 3 years of study enrollment
- Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to
starting study drug
- Increasing or chronic treatment (> 5 days) with corticosteroids or another
immunosuppressive agent
- Active heart (cardiac) disease as defined in the protocol
- Known hypersensitivity or contraindications to use paclitaxel
- Pregnant or nursing (lactating) woman
- Certain scores on an anxiety and depression mood questionaire given at screening
- Other protocol defined criteria may apply
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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 2/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
1/08/2012
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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
1/06/2015
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Sample size
Target
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Accrual to date
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Final
416
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Sydney
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Novartis Investigative Site - Geelong
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Novartis Investigative Site - Parkville
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Novartis Investigative Site - Nedlands
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2060 - Sydney
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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Wirral
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective
and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01572727
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01572727
Download to PDF