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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
2011-005932-24
Secondary ID [2] 0 0
CBKM120F2202
Universal Trial Number (UTN)
Trial acronym
BELLE-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll)
Timepoint [1] 0 0
Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed
Secondary outcome [1] 0 0
Overall Survival by Kaplan-Meier Estimate (Phase ll)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Overall Response Rate (Phase ll)
Timepoint [2] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [3] 0 0
Duration of Response (Phase Lll)
Timepoint [3] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [4] 0 0
Time to Response (Phase Lll)
Timepoint [4] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) (Phase ll)
Timepoint [5] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [6] 0 0
Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)
Timepoint [6] 0 0
Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.
Secondary outcome [7] 0 0
Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)
Timepoint [7] 0 0
every 4 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
416
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [4] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2060 - Sydney
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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Arkansas
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United States of America
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California
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Colorado
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Florida
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Georgia
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Kansas
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United States of America
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Kentucky
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Missouri
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Nebraska
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New Mexico
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New York
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Ohio
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Oklahoma
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Oregon
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Texas
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Virginia
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Charleroi
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Belgium
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Liege
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Belgium
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Liège
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Belgium
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Ottignies
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Belgium
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Sint-Niklaas
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Belgium
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Wilrijk
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Brazil
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CE
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Brazil
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Quebec
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Brno
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Olomouc
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Czech Republic
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Praha 2
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France
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Angers Cedex 02
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France
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Bordeaux
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France
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Creteil
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France
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La Roche sur Yon cedex 9
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France
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Le Mans Cedex
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France
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Marseille
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France
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Nice Cedex 2
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France
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Saint Herblain cedex
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France
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Toulouse Cedex 9
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France
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Erlangen
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Frankfurt
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Germany
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Fulda
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Germany
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Mainz
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Germany
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Muenchen
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Ulm
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Debrecen
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Szolnok
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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FE
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Italy
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GE
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Italy
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MB
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ME
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Italy
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MI
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Aichi
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Hokkaido
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Kanagawa
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Kumamoto
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Osaka
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Tokyo
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Korea, Republic of
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Korea
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Breda
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Netherlands
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Rotterdam
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Russian Federation
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Russia
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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South Africa
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Johannesburg
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Andalucia
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Catalunya
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Comunidad Valenciana
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Galicia
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Santa Cruz de Tenerife
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Madrid
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Zaragoza
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Taoyuan/ Taiwan ROC
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New Taipei City
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Taipei
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United Kingdom
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Kent
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Glasgow - Scotland
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London
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United Kingdom
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01572727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01572727