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AzTrials

Breast CancerPhase 3BELLE-2NCT01610284

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

A Phase 3 study testing Fulvestrant and BKM120 in people with Breast Cancer, run by Novartis Pharmaceuticals at 268 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
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
1,147 participants
Where
268 sitesin 29 countries
Study dates
7 Aug 2012to 19 Apr 2019
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

268 sites in 29 countries.

268 sites in 29 countries

United States61 sites

  • Shapiro and Stafford and Yee and Polanski Study Coordinator

    Arcadia, California, 91007

  • Mercy Medical Center Mercy Medical SC

    Baltimore, Maryland, 21202

  • Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins

    Baltimore, Maryland, 21231

  • St. Luke's Hospital and Health Network St Luke's (2)

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital SC

    Boston, Massachusetts, 02114

  • Hackensack Meridian Health

    Brick, New Jersey, 08724

  • Charleston Hematology Oncology Association PA

    Charleston, South Carolina, 29414

  • Levine Cancer Institute Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Case Western Reserve SC

    Cleveland, Ohio, 44106-5000

  • Texas Oncology P A Midtown

    Dallas, Texas, 75251

  • Texas Oncology P A TX Onc - Bedford

    Dallas, Texas, 75251

  • Texas Oncology P A TX Onc - Med City Dallas

    Dallas, Texas, 75251

  • Texas Oncology P A TX Onc - Southwest

    Dallas, Texas, 75251

  • Georgia Cancer Specialists SC

    Decatur, Georgia, 30033

  • Kaiser Permanente Northwest Kaiser

    Denver, Colorado

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Frederick Memorial Hospital Fred. Mem. Hosp.

    Frederick, Maryland, 21701

  • Cancer Care Associates Dept.ofCancerCareAssoc.

    Fresno, California, 93720

  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center

    Fullerton, California, 92835

  • Cadence Health

    Geneva, Illinois, 60134

  • Cancer TEAM Bellin Health Belin Health

    Green Bay, Wisconsin, 54313

  • Rocky Mountain Cancer Centers RMCC

    Greenwood Village, Colorado

  • Memorial Regional Cancer Center MRCC

    Hollywood, Florida, 33021

  • Oncology Consultants Oncology Consultants, P.A.

    Houston, Texas, 77024

  • Cancer Specialists of North Florida SC - F2302

    Jacksonville, Florida, 32258

  • West Michigan Cancer Center Dept of Oncology

    Kalamazoo, Michigan, 49007

  • Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

    Kennewick, Washington, 99336

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • University of California San Diego - Moores Cancer Center UCSD 3

    La Jolla, California, 92093-0658

  • Clinical Research Alliance SC-2

    Lake Success, New York, 11042

  • Los Angeles Hematology/Oncology Medical Group LA Cancer Network

    Los Angeles, California, 90017

  • USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)

    Los Angeles, California, 90053

  • University of California at Los Angeles Dept. of UCLA

    Los Angeles, California, 90095

  • Dean Health System Dean Hematology Oncology

    Madison, Wisconsin, 53717

  • University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

    Madison, Wisconsin, 53792-6164

  • University of Miami Univ Miami 2

    Miami, Florida, 33136

  • University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)

    Mobile, Alabama, 36688

  • West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology

    Morgantown, West Virginia, 26506

  • Cancer Care and Hematology Specialists of Chicagoland Niles

    Multiple Locations, Illinois

  • Vanderbilt University Medical Center Vanderbilt - Thompson Ln

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Dept Onc

    New York, New York, 10017

  • MD Anderson Cancer Center - Orlando MD Orlando

    Orlando, Florida, 32806

  • Ventura County Hematology and Oncology PMK Medical Group

    Oxnard, California, 93030

  • The Valley Hospital / Luckow Pavillion

    Paramus, New Jersey, 07652

  • Arizona Oncology Associates Dept of Oncology

    Phoenix, Arizona

  • Northwest Cancer Specialists Portland Loc

    Portland, Oregon, 97210

  • Oncology Hematology Associates of Southeast Virginia Salem VA Branch

    Roanoke, Virginia, 24014

  • University of Rochester Medical Center Univ Rochester

    Rochester, New York, 14642

  • Maryland Oncology Hematology, P.A. SC

    Rockville, Maryland, 20850

  • Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

    Salt Lake City, Utah, 84106

  • Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development

    San Antonio, Texas, 78229

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Santa Barbara Hematolgy Oncology Medical Group

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • St Joseph Heritage Healthcare Dept. of RRMG (4)

    Santa Rosa, California, 94503

  • Washington University School of Medicine Regulatory

    St Louis, Missouri, 63110

  • Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint

    Tupelo, Mississippi, 38801

  • Granada Hills Cancer Center

    Valencia, California, 91355

  • Cancer Center of Kansas CCK

    Wichita, Kansas, 67214-3728

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain28 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08024

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Elche, Alicante, 03203

  • Novartis Investigative Site

    Jaén, Andalusia, 23007

  • Novartis Investigative Site

    Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, 35016

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28050

  • Novartis Investigative Site

    Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    San Sebastián de los Reyes, Madrid, 28702

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Tarragona, Catalonia, 43007

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Valencia, Valencia, 46009

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46026

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Italy22 sites

  • Novartis Investigative Site

    Aviano, PN, 33081

  • Novartis Investigative Site

    Bologna, 40138

  • Novartis Investigative Site

    Catanzaro, CZ, 88100

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Cuneo, CN, 12100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Lido di Camaiore, LU, 55041

  • Novartis Investigative Site

    Meldola, FC, 47014

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Mirano, VE, 30035

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Province of Macerata, MC, 62100

  • Novartis Investigative Site

    Rimini, RN, 47900

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Torino, TO, 10126

Other trials in Italy

France19 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Avignon, 84082

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Clermont-Ferrand, 63011

  • Novartis Investigative Site

    Dijon, Cote D Or, 21034

  • Novartis Investigative Site

    Le Mans, 72015

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75231

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Saint Priest En Jarez, Pays de la Loire Region, 42270

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Villejuif, 94800

Other trials in France

Germany16 sites

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Hamburg, 20249

  • Novartis Investigative Site

    Hanover, 30177

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Langen, Hesse, 63225

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23563

  • Novartis Investigative Site

    Magdeburg, 39108

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, 68165

  • Novartis Investigative Site

    Mühlhausen, 99974

  • Novartis Investigative Site

    München, 80638

  • Novartis Investigative Site

    Recklinghausen, North Rhine-Westphalia, 45657

  • Novartis Investigative Site

    Saarbrücken, 66113

  • Novartis Investigative Site

    Velbert, 42551

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

Canada15 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 3G2

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 1V7

  • Novartis Investigative Site

    Kelowna, British Columbia, V1Y 5L3

  • Novartis Investigative Site

    Laval, Quebec, H7M 3L9

  • Novartis Investigative Site

    London, Ontario, N6A 4L6

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Newmarket, Ontario, J7Y 2P9

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1S 4L8

  • Novartis Investigative Site

    Regina, Saskatchewan, S4T 7T1

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Japan13 sites

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1395

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193

  • Novartis Investigative Site

    Kashiwa, Chiba, 277 8577

  • Novartis Investigative Site

    Koto Ku, Tokyo, 135 8550

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006

  • Novartis Investigative Site

    Osaka, Osaka, 541-8567

  • Novartis Investigative Site

    Sakyo Ku, Kyoto, 606 8507

  • Novartis Investigative Site

    Sapporo, Hokkaido, 003-0804

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

China10 sites

  • Novartis Investigative Site

    Beijing, 100039

  • Novartis Investigative Site

    Changsha, Hunan, 410013

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200032

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shengyang, Liaoning, 110042

Other trials in China

United Kingdom9 sites

  • Novartis Investigative Site

    Bournemouth, BH7 7DW

  • Novartis Investigative Site

    Derby, DE22 3NE

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    Liverpool, L7 8XP

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    London, WC1E 6HX

  • Novartis Investigative Site

    Manchester, M20 2BX

  • Novartis Investigative Site

    Oxford, OX3 7LJ

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Australia7 sites

  • Novartis Investigative Site

    Clayton, Victoria, 3168

  • Novartis Investigative Site

    Melbourne, Victoria, 3000

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    Sydney, New South Wales, 2060

  • Novartis Investigative Site

    Woollongong, New South Wales, 2500

Other trials in Australia

Belgium7 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Jette, Brussels Capital, 1090

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Brazil7 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784 400

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-270

  • Novartis Investigative Site

    Curitiba, Paraná, 81520-060

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700-000

  • Novartis Investigative Site

    Natal, Rio Grande do Norte, 59075 740

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246 000

  • Novartis Investigative Site

    Sorocaba, São Paulo

Other trials in Brazil

Israel5 sites

  • Novartis Investigative Site

    Haifa, 3525408

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Russia5 sites

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 115998

  • Novartis Investigative Site

    Nizhny Novgorod, 603081

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

South Korea5 sites

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 443380

Other trials in South Korea

Taiwan5 sites

  • Novartis Investigative Site

    Kaohsiung City, 80756

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taipei, 10048

  • Novartis Investigative Site

    Taipei, 112

Other trials in Taiwan

Argentina4 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7600CTO

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Greece4 sites

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Pátrai, 265 00

  • Novartis Investigative Site

    Thessaloniki, GR, 54645

Other trials in Greece

Hungary4 sites

  • Novartis Investigative Site

    Budapest, H 1122

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

Austria3 sites

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Czechia3 sites

  • Novartis Investigative Site

    Brno, 65653

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Olomouc, CZE, 775 20

Other trials in Czechia

Poland3 sites

  • Novartis Investigative Site

    Krakow

  • Novartis Investigative Site

    Olsztyn, 10-513

  • Novartis Investigative Site

    Warsaw, 02-776

Other trials in Poland

Switzerland3 sites

  • Novartis Investigative Site

    Bellinzona, 6500

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Zurich, 8038

Other trials in Switzerland

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

Slovakia2 sites

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 83310

  • Novartis Investigative Site

    Košice, 041 91

Other trials in Slovakia

South Africa2 sites

  • Novartis Investigative Site

    Johannesburg, 2196

  • Novartis Investigative Site

    Parktown, 2193

Other trials in South Africa

Netherlands1 site

  • Novartis Investigative Site

    Nijmegen, 6500 HB

Other trials in Netherlands

Peru1 site

  • Novartis Investigative Site

    Surquillo, Lima region, 34

Other trials in Peru

Singapore1 site

  • Novartis Investigative Site

    Singapore, 169610

Other trials in Singapore

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 Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

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.

Read the detailed description

Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors [RECIST] version 1.1).

Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).

Conditions
Breast Cancer
Being tested
Fulvestrant, BKM120, BKM120 matching placebo
Keywords
Breast cancer, Hormone receptor positive, HER2-negative, Metastatic, Locally advanced, PI3K, Fulvestrant, Refractory, Aromatase inhibitor
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

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 NCT01610284
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) in Full Population, Main Study Cohort and PI3K Unknown Cohort

    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.

    Measured: 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

Secondary outcomes (8)

  1. Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort

    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.

    Measured: Every 3 months following end of treatment visit, assessed for approximately 5 years

  2. Overall Response Rate (ORR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort

    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.

    Measured: 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

  3. Clinical Benefit Rate (CBR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort

    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.

    Measured: 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

  4. Number of Participants With On-Treatments Adverse Events, Serious Adverse Events and Deaths

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

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

  5. Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 2 Day 1

    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.

    Measured: Cycle2 Day1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose). Each cycle is 28 days.

  6. 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 2 Day 1, Cycle 2 Day 15 and Cycle 3 Day 1. Each cycle is 28 days. Only descriptive analysis performed.

    Measured: Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1. Each cycle is 28 days.

  7. Median Time to Definitive Deterioration of the ECOG Performance Status - Full Analysis Set (FAS)

    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.

    Measured: Up to approx 27 months

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

    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.

    Measured: Cycle 1 day 1, cycle 1 day 15, 6 weeks after randomisation and then every 8 weeks until end of treatment

Timeline

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

  1. First posted4 Jun 2012 (estimated)
  2. Study start7 Aug 2012
  3. Primary completion29 Apr 2015
  4. Study completion19 Apr 2019

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
1,147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01610284
Sponsor's protocol ID
CBKM120F2302
Other IDs
2011-005524-17
Acronym
BELLE-2
Status last verified
Aug 2020
First submitted
11 May 2012
Last updated
25 Aug 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

  • Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortes J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaer S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2. Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18.

    PubMed 30241001

  • Baselga J, Im SA, Iwata H, Cortes J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):904-916. doi: 10.1016/S1470-2045(17)30376-5. Epub 2017 May 30.

    PubMed 28576675

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and BKM120 in people with Breast Cancer, run by Novartis Pharmaceuticals at 268 sites in 29 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Spain, Italy, France, Germany and 24 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 18 Jun 2020). 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) in Full Population, Main Study Cohort and PI3K Unknown Cohort (time frame: 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). 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 NCT01610284, which also lists 2 linked publications.

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 25 Aug 2020.

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