Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT02437318

Novartis Reference Number: CBYL719C2301

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

Condition 
Breast Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
572 participants
Start date 
Jul 23, 2015
Completion date 
Jun 30, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Fulvestrant
Drug
Alpelisib
Drug
Alpelisib placebo

Eligibility Criteria

Inclusion Criteria:

If female, patient is postmenopausal
Patient has identified PIK3CA status

Patients may be:

relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy
Patient has recurrence or progression of disease during or after AI therapy (i.e.

letrozole, anastrozole, exemestane).

Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
Patient has adequate bone marrow function

Exclusion Criteria:

Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
Patient with inflammatory breast cancer at screening
Patients with Child pugh score B or C
Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more
Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy completion to starting the study treatment and has stable CNS tumor at time of screening and not receiving steroids and/or enzyme inducing ant-epileptic medications for brain metastases
Patient has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease

Other protocol-defined inclusion/esclusion criteria may apply.

Study Locations

United States
Ironwood Cancer and Research Centers Chandler 2
-
Chandler, 85224
Arizona
United States
Mayo Clinic - Arizona
-
Scottsdale, 85259
Arizona
United States
Highlands Oncology Group
-
Fayetteville, 72703
Arkansas
United States
Beverly Hills Cancer Center
-
Beverly Hills, 90211
California
United States
City of Hope National Medical Center
-
Duarte, 91010 3000
California
United States
Scripps Clinic SC
-
La Jolla, 92037
California
United States
Kaiser Permanente - California Southern
-
San Diego, 92120
California
United States
University of California San Francisco
-
San Francisco, 94115
California
United States
Florida Cancer Specialists FL Cancer Specialists
-
Fort Myers, 33901
Florida
United States
Florida Cancer Specialists - North SC
-
Saint Petersburg, 33705
Florida
United States
Rush University Medical Center Rush Uni Medical Center
-
Chicago, 60612
Illinois
United States
North Shore University Health System NorthShore University
-
Evanston, 60201
Illinois
United States
Edward Cancer Center SC
-
Naperville, 60540
Illinois
United States
Fort Wayne Medical Oncology/Hematology, Inc. Dept.of Fort Wayne Med Onc/Hem
-
Fort Wayne, 46815
Indiana
United States
St. Francis Health Comprehensive Cancer Center SC
-
Topeka, 66606-169
Kansas
United States
Mercy Medical Center SC-2
-
Baltimore, 21202
Maryland
United States
Massachusetts General Hospital Updated Regulatory
-
Boston, 02114
Massachusetts
United States
Lahey Clinic
-
Burlington, 01805
Massachusetts
United States
Detroit Clinical Research Center
-
Owosso, 48867
Michigan
United States
St. Luke's Cancer Institute SC
-
Kansas City, 64111
Missouri
United States
St Vincent Frontier Cancer Center
-
Billings, 59102
Montana
United States
Rutgers Cancer Institute of New Jersey SC-2
-
New Brunswick, 08903
New Jersey
United States
University Hospitals of Cleveland Seidman Cancer Center SC
-
Cleveland, 44106
Ohio
United States
Good Samaritan Regional Medical Center Good Samaritan Reg Med Ctr
-
Corvallis, 97330
Oregon
United States
Lancaster General Hospital
-
Lancaster, 17604
Pennsylvania
United States
Greenville Health System SC-2
-
Greenville, 29615
South Carolina
United States
Avera Cancer SC
-
Sioux Falls, 57105
South Dakota
United States
Tennessee Oncology SC-3
-
Nashville, 37203
Tennessee
United States
Texas Oncology PA Dallas Presbyterian Hospital SC-1
-
Dallas, 75231
Texas
United States
El Paso, Texas Oncology
-
El Paso, 79902
Texas
United States
Cancer Therapy and Research Center UT Health Science Center InstituteForDrugDevelopment(4)
-
San Antonio, 78229
Texas
United States
US Oncology P A
-
Tyler, 75702
Texas
United States
Virginia Cancer Specialists SC
-
Fairfax, 22031
Virginia
United States
Wenatchee Valley Medical Center SC-2
-
Wenatchee, 98801
Washington
United States
Argentina
Novartis Investigative Site
-
Berazategui, B1884BBF
Buenos Aires
Argentina
Novartis Investigative Site
-
Caba, C1125ABD
Buenos Aires
Argentina
Novartis Investigative Site
-
Rio Negro, 8500
Viedma
Argentina
Novartis Investigative Site
-
La Rioja, 5300
-
Argentina
Australia
Novartis Investigative Site
-
Wahroonga, 2076
New South Wales
Australia
Novartis Investigative Site
-
Wooloongabba, 4102
Queensland
Australia
Novartis Investigative Site
-
Elizabeth Vale, 5112
South Australia
Australia
Novartis Investigative Site
-
Melbourne, 3000
Victoria
Australia
Austria
Novartis Investigative Site
-
Linz, 4010
-
Austria
Novartis Investigative Site
-
Vienna, 1090
-
Austria
Belgium
Novartis Investigative Site
-
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
-
Jette, 1090
Brussel
Belgium
Novartis Investigative Site
-
Sint Niklaas, 9100
Vlaams Brabant
Belgium
Novartis Investigative Site
-
Bruxelles, 1000
-
Belgium
Novartis Investigative Site
-
Libramont, 6800
-
Belgium
Novartis Investigative Site
-
Ottignies, 1340
-
Belgium
Novartis Investigative Site
-
Verviers, 4800
-
Belgium
Brazil
Novartis Investigative Site
-
Natal, 59075 740
RN
Brazil
Novartis Investigative Site
-
Lajeado, 95900-000
RS
Brazil
Novartis Investigative Site
-
Sao Paulo, 03102-002
SP
Brazil
Novartis Investigative Site
-
Sao Jose do Rio Preto, 15090 000
-
Brazil
Novartis Investigative Site
-
Sao Paulo, 01236 030
-
Brazil
Bulgaria
Novartis Investigative Site
-
Plovdiv, 4004
-
Bulgaria
Novartis Investigative Site
-
Sofia, 1756
-
Bulgaria
Novartis Investigative Site
-
Varna, 9002
-
Bulgaria
Novartis Investigative Site
-
Varna, 9010
-
Bulgaria
Canada
Novartis Investigative Site
-
Calgary, T2N 4N2
Alberta
Canada
Novartis Investigative Site
-
Cambridge, N1R 3G2
Ontario
Canada
Novartis Investigative Site
-
Ottawa, KIH 7W9
Ontario
Canada
Novartis Investigative Site
-
Toronto, M5B 1W8
Ontario
Canada
Novartis Investigative Site
-
Quebec, G1S 4L8
-
Canada
Chile
Novartis Investigative Site
-
Temuco, 4810469
Araucania
Chile
Novartis Investigative Site
-
Santiago, 8420383
-
Chile
Novartis Investigative Site
-
Vina del Mar, 2520612
-
Chile
Czechia
Novartis Investigative Site
-
Hradec Kralove, 500 05
Czech Republic
Czechia
Novartis Investigative Site
-
Praha 4, 140 46
Czech Republic
Czechia
Novartis Investigative Site
-
Zlin, 762 75
Czech Republic
Czechia
Novartis Investigative Site
-
Prague 8, 180 00
-
Czechia
France
Novartis Investigative Site
-
Marseille cedex 20, 13915
Bouches Du Rhone
France
Novartis Investigative Site
-
Angers cedex 02, 49055
-
France
Novartis Investigative Site
-
Avignon Cedex, 84082
-
France
Novartis Investigative Site
-
Caen Cedex, 14021
-
France
Novartis Investigative Site
-
Clermont-Ferrand, 63011
-
France
Novartis Investigative Site
-
Creteil, 94010
-
France
Novartis Investigative Site
-
La Roche sur Yon cedex 9, 85925
-
France
Novartis Investigative Site
-
Le Chesnay, 78157
-
France
Novartis Investigative Site
-
Levallois-Perret, 92309
-
France
Novartis Investigative Site
-
Lyon Cedex 08, 69373
-
France
Novartis Investigative Site
-
Montpellier, 34070
-
France
Novartis Investigative Site
-
Nimes, 30029
-
France
Novartis Investigative Site
-
Rouen Cedex 1, 76038
-
France
Novartis Investigative Site
-
Saint-Herblain Cédex, 44805
-
France
Novartis Investigative Site
-
Toulouse Cedex 9, 31059
-
France
Novartis Investigative Site
-
Villejuif Cedex, 94800
-
France
Germany
Novartis Investigative Site
-
Recklinghausen, 45657
North Rhine-westphalia
Germany
Novartis Investigative Site
-
Leipzig, 04277
Sachsen
Germany
Novartis Investigative Site
-
Luebeck, 23563
Schleswig-holstein
Germany
Novartis Investigative Site
-
Aschaffenburg, 63739
-
Germany
Novartis Investigative Site
-
Frankfurt, 60389
-
Germany
Novartis Investigative Site
-
Friedrichshafen, 88045
-
Germany
Novartis Investigative Site
-
Hannover, 30625
-
Germany
Novartis Investigative Site
-
Homburg, 66421
-
Germany
Novartis Investigative Site
-
Kiel, 24105
-
Germany
Novartis Investigative Site
-
Mainz, 55131
-
Germany
Novartis Investigative Site
-
Potsdam, 14467
-
Germany
Novartis Investigative Site
-
Rostock, 18059
-
Germany
Novartis Investigative Site
-
Ulm, 89081
-
Germany
Novartis Investigative Site
-
Velbert, 42551
-
Germany
Greece
Novartis Investigative Site
-
Thessaloniki, 564 29
GR
Greece
Novartis Investigative Site
-
Athens, 115 28
-
Greece
Novartis Investigative Site
-
Athens, 18547
-
Greece
Hong Kong
Novartis Investigative Site
-
Hong Kong,
-
Hong Kong
Hungary
Novartis Investigative Site
-
Budapest, 1134
-
Hungary
Novartis Investigative Site
-
Budapest, H 1122
-
Hungary
Novartis Investigative Site
-
Nyiregyhaza, 4400
-
Hungary
Novartis Investigative Site
-
Szekszard, 7100
-
Hungary
India
Novartis Investigative Site
-
Vijayawada, 520002
Andhra Pradesh
India
Novartis Investigative Site
-
Nagpur - Maharashtra, 440010
Maharashtra
India
Novartis Investigative Site
-
Mumbai, 400 012
-
India
Israel
Novartis Investigative Site
-
Beer-Sheva, 8457108
-
Israel
Novartis Investigative Site
-
Haifa, 3525408
-
Israel
Novartis Investigative Site
-
Petach Tikva, 49100
-
Israel
Novartis Investigative Site
-
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
-
Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
-
Ancona, 60126
AN
Italy
Novartis Investigative Site
-
Chieti, 66100
CH
Italy
Novartis Investigative Site
-
Meldola, 47014
FC
Italy
Novartis Investigative Site
-
Milano, 20133
MI
Italy
Novartis Investigative Site
-
Palermo, 90127
PA
Italy
Novartis Investigative Site
-
Padova, 35100
PD
Italy
Novartis Investigative Site
-
Pontedera, 56025
PI
Italy
Novartis Investigative Site
-
Aviano, 33081
PN
Italy
Novartis Investigative Site
-
Rionero in Vulture, 85028
PZ
Italy
Novartis Investigative Site
-
Roma, 00155
RM
Italy
Novartis Investigative Site
-
Sassari, 07100
SS
Italy
Novartis Investigative Site
-
Savona, 17100
SV
Italy
Novartis Investigative Site
-
Torino, 10126
TO
Italy
Novartis Investigative Site
-
Negrar, 37024
VR
Italy
Japan
Novartis Investigative Site
-
Nagoya, 464 8681
Aichi
Japan
Novartis Investigative Site
-
Matsuyama, 791-0280
Ehime
Japan
Novartis Investigative Site
-
Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
-
Sapporo-city, 003-0804
Hokkaido
Japan
Novartis Investigative Site
-
Akashi, 673-8558
Hyogo
Japan
Novartis Investigative Site
-
Kagoshima-city, 892-0833
Kagoshima
Japan
Novartis Investigative Site
-
Isehara, 259-1193
Kanagawa
Japan
Novartis Investigative Site
-
Yokohama-city, 241-8515
Kanagawa
Japan
Novartis Investigative Site
-
Kumamoto City, 860-8556
Kumamoto
Japan
Novartis Investigative Site
-
Osaka-city, 540-0006
Osaka
Japan
Novartis Investigative Site
-
Osaka-city, 541-8567
Osaka
Japan
Novartis Investigative Site
-
Kitaadachi-gun, 362-0806
Saitama
Japan
Novartis Investigative Site
-
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
-
Minato ku, 105-8470
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
-
Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
-
Gyeonggi do, 10408
Korea
Korea, Republic of
Novartis Investigative Site
-
Seoul, 05505
Korea
Korea, Republic of
Novartis Investigative Site
-
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
-
Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
-
Seoul, 06351
-
Korea, Republic of
Lebanon
Novartis Investigative Site
-
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
-
Beirut,
-
Lebanon
Novartis Investigative Site
-
Saida, 652
-
Lebanon
Mexico
Novartis Investigative Site
-
Monterrey, N.L., 64320
Monterrey
Mexico
Novartis Investigative Site
-
San Luis Potosi, 78200
-
Mexico
Netherlands
Novartis Investigative Site
-
Venray, 5801
CE
Netherlands
Novartis Investigative Site
-
Terneuzen, 4535 PA
-
Netherlands
Peru
Novartis Investigative Site
-
San Borja, 41
Lima
Peru
Novartis Investigative Site
-
Surquillo, 34
Lima
Peru
Novartis Investigative Site
-
Lima, LIMA 27
-
Peru
Romania
Novartis Investigative Site
-
Floresti, 407280
Cluj
Romania
Novartis Investigative Site
-
Craiova, 200347
Dolj
Romania
Novartis Investigative Site
-
Iasi, 700483
-
Romania
Russian Federation
Novartis Investigative Site
-
Arkhangelsk, 163045
-
Russian Federation
Novartis Investigative Site
-
Ryazan, 390011
-
Russian Federation
Novartis Investigative Site
-
St Petersburg, 197758
-
Russian Federation
Spain
Novartis Investigative Site
-
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
-
Jerez, 11407
Cadiz
Spain
Novartis Investigative Site
-
Badalona, 08916
Catalunya
Spain
Novartis Investigative Site
-
Barcelona, 08024
Cataluña
Spain
Novartis Investigative Site
-
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Castellon, 12002
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Badajoz, 06080
Extremadura
Spain
Novartis Investigative Site
-
Caceres, 10003
Extremadura
Spain
Novartis Investigative Site
-
Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
-
Palma De Mallorca, 07120
Islas Baleares
Spain
Novartis Investigative Site
-
Pozuelo de Alarcon, 28223
Madrid
Spain
Novartis Investigative Site
-
El Palmar, 30120
Murcia
Spain
Novartis Investigative Site
-
La Laguna, 38320
Santa Cruz De Tenerife
Spain
Novartis Investigative Site
-
Madrid, 28034
-
Spain
Novartis Investigative Site
-
Madrid, 28040
-
Spain
Novartis Investigative Site
-
Madrid, 28041
-
Spain
Novartis Investigative Site
-
Madrid, 28046
-
Spain
Novartis Investigative Site
-
Madrid, 28050
-
Spain
Sweden
Novartis Investigative Site
-
Gavle, SE-801 87
-
Sweden
Novartis Investigative Site
-
Oerebro, 70185
-
Sweden
Novartis Investigative Site
-
Vasteras, 721 89
-
Sweden
Taiwan
Novartis Investigative Site
-
Taipei, 10002
-
Taiwan
Novartis Investigative Site
-
Taipei, 11217
-
Taiwan
Thailand
Novartis Investigative Site
-
Bangkok, 10330
THA
Thailand
Novartis Investigative Site
-
Bangkok, 10700
-
Thailand
United Kingdom
Novartis Investigative Site
-
Plymouth, PL6 8DH
Devon
United Kingdom
Novartis Investigative Site
-
Leicester, LE1 5WW
-
United Kingdom
Novartis Investigative Site
-
London, SE1 9RT
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]