AzTrials
AzTrials

Metastatic Breast CancerPhase 3BELLE-3NCT01633060

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

A Phase 3 study testing Fulvestrant and BKM120 in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 197 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Fulvestrant and BKM120
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
432 participants
Where
197 sitesin 22 countries
Study dates
3 Oct 2012to 21 Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients age 18 years or older
  • Histologically and/or cytologically confirmed diagnosis of breast cancer
  • Radiologic evidence of inoperable locally advanced or metastatic breast cancer
  • Adequate tumor tissue for the analysis of PI3K-related biomarkers
  • Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status
  • Postmenopausal women
Show all 10Show fewer
  • Prior treatment with aromatase inhibitors
  • 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
  • ECOG performance status ≤ 2

Who cannot join

  • Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant
  • More than one chemotherapy line for metastatic disease
  • Hypersensitivity to any of the excipients of buparlisib or fulvestrant
  • Symptomatic central nervous system metastases
  • Concurrent malignancy or malignancy within 3 years of study enrollment
  • Certain drugs or radiation within 2-4 weeks of enrollment
Show all 10Show fewer
  • Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent
  • Certain scores on an anxiety and depression mood questionnaire given at screening
  • Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus
  • Active cardiac disease or a history of cardiac dysfunction

Trial locations and contacts

197 sites in 22 countries.

197 sites in 22 countries

Italy38 sites

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Benevento, BN, 82100

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Brindisi, BR, 72100

  • Novartis Investigative Site

    Candiolo, TO, 10060

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Frattamaggiore, 80020

  • Novartis Investigative Site

    Ivrea, TO, 10015

  • Novartis Investigative Site

    L’Aquila, AQ, 67100

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Lecco, LC, 23900

  • Novartis Investigative Site

    Meldola, FC, 47014

  • Novartis Investigative Site

    Messina, ME, 98158

  • Novartis Investigative Site

    Milan, MI, 20121

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Mirano, VE, 30035

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Monserrato, CA, 09042

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Padova, PD, 35100

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Pordenone, PN, 33170

  • Novartis Investigative Site

    Prato, PO, 59100

  • Novartis Investigative Site

    Province of Macerata, MC, 62100

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Salerno, SA, 84131

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Sora, FR, 03039

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

United States37 sites

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Emory University School of Medicine/Winship Cancer Institute Emory

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center Univ Maryland

    Baltimore, Maryland, 21201

  • Ironwood Cancer and Research Centers SC

    Chandler, Arizona, 85224

  • Texas Oncology PA Dallas Presbyterian Hospital SC

    Dallas, Texas, 75231

  • Texas Oncology Texas Oncology - Sammons

    Dallas, Texas, 75246

  • Texas Oncology P A SC-Austin

    Dallas, Texas, 75251

  • Texas Oncology P A Texas Oncology - Fort Worth (3

    Dallas, Texas, 75251

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Rocky Mountain Cancer Centers SC

    Denver, Colorado, 80218

  • Texas Tech University Health Science Center Dept of Texas Tech

    El Paso, Texas, 79905

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Compassionate Cancer Care Medical Group CCCMG

    Fountain Valley, California, 92708

  • Moanalua Medical Center. Attn: Oncology Dept

    Honolulu, Hawaii, 96817

  • The Methodist Hospital Cancer Center

    Houston, Texas, 77030

  • Clinical Research Alliance BKM120F2303

    Lake Success, New York, 11042

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • Los Angeles Hematology/Oncology Medical Group Onc Dept.

    Los Angeles, California, 90017

  • Cedars Sinai Medical Center SC-5

    Los Angeles, California, 90048

  • University of California at Los Angeles UCLA SC

    Los Angeles, California, 90095

  • Mercy Medical Research Institute SC

    Manchester, Missouri, 63021

  • The West Clinic Dept. of the West Clinic

    Memphis, Tennessee, 38120

  • Crescent City Research Consortium, LLC SC

    Metairie, Louisiana, 70006

  • University of South Alabama / Mitchell Cancer Institute Univ South AL

    Mobile, Alabama, 36688

  • Pacific Cancer Care

    Monterey, California, 93940

  • Morristown Memorial Hospital Morristown Mem

    Morristown, New Jersey, 07962

  • Edward Hospital Edward Hospital

    Naperville, Illinois, 60540

  • Lsu Health Sciences Center/ Lsu School of Medicine Lsu

    New Orleans, Louisiana, 70115

  • John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2

    New Orleans, Louisiana, 70121

  • LSU Health Sciences Center Feist-Weiller Cancer Center

    New Orleans, Louisiana, 70122-2822

  • University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15232

  • Northwest Cancer Specialists Compass Oncology -BKM

    Portland, Oregon, 97210

  • Oregon Health and Science University SC-5

    Portland, Oregon, 97239

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Montefiore Medical Center Montefiore

    The Bronx, New York, 10467

  • US Oncology, P.A.

    Tyler, Texas, 75702

  • CINJ at Cooper University Hospital Dept of Onc

    Voorhees Township, New Jersey, 08043

Other trials in United States

Spain24 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Castellon, Valencia, 12002

  • Novartis Investigative Site

    Elche, Alicante, 03203

  • Novartis Investigative Site

    Jaén, Andalusia, 23007

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38009

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Valencia, Valencia, 46009

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46014

Other trials in Spain

Germany22 sites

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45136

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Fulda, 36043

  • Novartis Investigative Site

    Karlsruhe, 76135

  • Novartis Investigative Site

    Kiel, 24103

  • Novartis Investigative Site

    Leer, 26789

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mannheim, 68165

  • Novartis Investigative Site

    Mühlhausen, 99974

  • Novartis Investigative Site

    München, 80637

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Ravensburg, 88214

  • Novartis Investigative Site

    Soest, 59494

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Velbert, 42551

Other trials in Germany

France11 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Clermont-Ferrand, 63011

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189

  • Novartis Investigative Site

    Paris, 75231

  • Novartis Investigative Site

    Reims, Marne, 51056

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Saint-Brieuc Cédex, 22015

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, 92210

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

Other trials in France

Greece8 sites

  • Novartis Investigative Site

    Athens, GR, 151 23

  • Novartis Investigative Site

    Athens, 18547

  • Novartis Investigative Site

    Athens, GR-115 22

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Larissa, GR, 411 10

  • Novartis Investigative Site

    Marousi, Athens, 15123

  • Novartis Investigative Site

    Patra - RIO, GR, 265 04

  • Novartis Investigative Site

    Thesaloniki, Thessaloniki, 54622

Other trials in Greece

Netherlands8 sites

  • Novartis Investigative Site

    Breda, 4819 EV

  • Novartis Investigative Site

    Delft, NL 2625 AD

  • Novartis Investigative Site

    Deventer, 7416 SE

  • Novartis Investigative Site

    Hoofddorp, 2134 TM

  • Novartis Investigative Site

    Leiden, 2300 RC

  • Novartis Investigative Site

    Maastricht, AZ, 5800

  • Novartis Investigative Site

    Sittard-Geleen, 6162 BG

  • Novartis Investigative Site

    Zwolle, 8025 AB

Other trials in Netherlands

Bulgaria7 sites

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Plovdiv, 4004

  • Novartis Investigative Site

    Sofia, 1303

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9010

  • Novartis Investigative Site

    Vratsa, 3000

Other trials in Bulgaria

United Kingdom7 sites

  • Novartis Investigative Site

    Blackburn, Lancashire, BB2 3HH

  • Novartis Investigative Site

    Edinburgh, EH4 2XU

  • Novartis Investigative Site

    Ipswich, Suffolk, IP4 5PD

  • Novartis Investigative Site

    London, SM2 5PT

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    Manchester, M20 2BX

  • Novartis Investigative Site

    Nottingham, NG5 1PB

Other trials in United Kingdom

Argentina4 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Austria4 sites

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Belgium4 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Namur, 5000

Other trials in Belgium

Hungary4 sites

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Budapest, H-1122

  • Novartis Investigative Site

    Szeged, H-6720

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

South Korea4 sites

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, Korea, 05505

  • Novartis Investigative Site

    Seoul, 03722

Other trials in South Korea

Lebanon3 sites

  • Novartis Investigative Site

    Beirut

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

Sweden3 sites

  • Novartis Investigative Site

    Kalmar, SE-391 85

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Uppsala, 751 85

Other trials in Sweden

Canada2 sites

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1T8

  • Novartis Investigative Site

    Montreal, Quebec, H3A 1A1

Other trials in Canada

Colombia2 sites

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Montería

Other trials in Colombia

Norway2 sites

  • Novartis Investigative Site

    Bergen, 5021

  • Novartis Investigative Site

    Oslo, NO 0450

Other trials in Norway

Finland1 site

  • Novartis Investigative Site

    Tampere, FIN-33521

Other trials in Finland

Poland1 site

  • Novartis Investigative Site

    Olsztyn, 10226

Other trials in Poland

Thailand1 site

  • Novartis Investigative Site

    Bangkok, 10400

Other trials in Thailand

About this study

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

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

Read the detailed description

Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.

Being tested
Fulvestrant, BKM120, BKM120 matching placebo
Keywords
BKM120, fulvestrant, breast cancer, metastatic, locally advanced, AI treated, mTOR inhibitor, PI3K, PIK3CA, PTEN, HER2-, HR+
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)

  • BKM120Drug

    BKM120 100 mg once daily

  • BKM120 matching placeboDrug

    BKM120 matching placebo, once daily

Study groups in NCT01633060
Study groupRoleWhat they receive
BKM120 100mg + FulvestrantExperimentalBKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
Receives: Drug: Fulvestrant; Drug: BKM120
Placebo + FulvestrantPlacebo comparatorBKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Receives: Drug: Fulvestrant; Drug: BKM120 matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)

    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. Patients were followed up for approximately every 6 weeks after randomization.

    Measured: Every 6 weeks after randomization up to a maximum of 4 years

Secondary outcomes (10)

  1. Overall Survival (OS) - Full Analysis Set (FAS)

    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 approximately every 6 weeks after randomization and every 3 months during survival follow-up.

    Measured: Every 6 weeks after randomization up to a maximum of 5 years

  2. Progression Free Survival (PFS) by PIK3CA Mutational Status

    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. Patients were followed up for approximately every 6 weeks after randomization.

    Measured: Every 6 weeks after randomization up to a maximum of 5 years

  3. Overall Survival (OS) by PIK3CA Mutational Status

    Overall Survival (OS) by PIK3CA mutational status based on ctDNA 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 approximately every 6 weeks after randomization and every 3 months during survival follow-up.

    Measured: Every 6 weeks after randomization up to a maximum of 5 years

  4. Overall Response Rate (ORR) by PIK3CA Mutational Status

    Overall Response Rate (ORR) is defined as the proportion 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 and by PIK3CA mutational status based on ctDNA. 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. Patients were followed up for the duration of the study and for approximately every 6 weeks after randomization.

    Measured: Every 6 weeks after randomization up to a maximum of 5 years

  5. Clinical Benefit Rate (CBR) by PIK3CA Mutational Status

    Clinical Benefit Rate (CBR) is defined as the proportion 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 14 or 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Patients were followed up for the duration of the study and approximately every 6 weeks after randomization.

    Measured: Week 14, Week 24

  6. Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)

    Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths.

    Measured: From first dose of study treatment to 30 days after last dose of study treatment, up to 5 years

  7. Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)

    Plasma samples were collected from the first 100 BKM120-treated patients on Cycle 1 Day 1 (at 1h, 2h, and 6h post-dose and a recommended 9h post-dose sample).

    Measured: C1D1 1 hour post dose, C1D1 2 hour post dose, C1D1 6 hour post dose and C1D1 9 hour post dose

  8. Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)

    Pre-dose samples were collected for trough concentrations at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1.

    Measured: C1D15, C2D1, C3D1 and C4D1

  9. Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)

    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.

    Measured: Baseline, Week 6 (C2D15), Week 12 (C4D1), then every 8 weeks until discontinuation (a cycle [C] = 4 weeks) up to 5 years.

  10. Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)

    The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The ECOG Performance Scores has 5 grades: 0 = fully active, able to carry on all pre-disease performance without restriction, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work, 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours, 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 = dead. Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.

    Measured: Screening, Baseline (Cycle 1 Day 1) and then at day 1 of each cycle and at the EOT visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study start3 Oct 2012
  3. Primary completion23 May 2016
  4. Study completion21 Sep 2017

Why it stopped: Novartis decided not to pursue further development of buparlisib program (assessment of moderate PFS benefit with know, but manageable, buparlisib profile).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633060
Sponsor's protocol ID
CBKM120F2303
Other IDs
2012-002571-34
Acronym
BELLE-3
Status last verified
Jan 2019
First submitted
29 Jun 2012
Last updated
30 Jan 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7.

    PubMed 29223745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and BKM120 in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 197 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in Italy, United States, Spain, Germany, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) (time frame: Every 6 weeks after randomization up to a maximum of 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01633060, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in