Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02437318
Registration number
NCT02437318
Ethics application status
Date submitted
22/04/2015
Date registered
7/05/2015
Date last updated
18/11/2023
Titles & IDs
Public title
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.
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
2015-000340-42
Query!
Secondary ID [2]
0
0
CBYL719C2301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SOLAR-1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Alpelisib
Treatment: Drugs - Alpelisib placebo
Experimental: fulvestrant + alpelisib - Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Placebo Comparator: fulvestrant + placebo - Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Treatment: Drugs: Fulvestrant
Treatment: Drugs: Alpelisib
Treatment: Drugs: Alpelisib placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
Query!
Assessment method [1]
0
0
PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1
Query!
Timepoint [1]
0
0
Once approximately 243 PFS events in this cohort had been observed, up to 32 months
Query!
Secondary outcome [1]
0
0
Overall Survival (OS) for Patients With PI3KCA Mutant Status
Query!
Assessment method [1]
0
0
OS is defined as the time from date of randomization to date of death due to any cause.
Query!
Timepoint [1]
0
0
Up to approximatly 59 months
Query!
Secondary outcome [2]
0
0
Overall Response Rate (ORR)
Query!
Assessment method [2]
0
0
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1.
Query!
Timepoint [2]
0
0
Up to approximatly 36 months
Query!
Secondary outcome [3]
0
0
Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Query!
Assessment method [3]
0
0
Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Query!
Timepoint [3]
0
0
Baseline, Up to approximatly 36 months
Query!
Secondary outcome [4]
0
0
Safety and Tolerability of Alpelisib in Combination With Fulvestrant
Query!
Assessment method [4]
0
0
Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study.
Query!
Timepoint [4]
0
0
Up to approximatly 37 months
Query!
Secondary outcome [5]
0
0
Time to 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30
Query!
Assessment method [5]
0
0
Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized
Query!
Timepoint [5]
0
0
Up to approximatly 36 months
Query!
Secondary outcome [6]
0
0
Plasma Concentration-time Profile of Alpelisib Given in Combinatio With Fulvestrant and Appropriate Pharmacokinetics (PK) Parameters
Query!
Assessment method [6]
0
0
Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples. PK parameters includes,but not limited to, Cmin, Cmax, t1/2, AUClast for alpelisib (and any relevant metabolites) and fulvestrant
Query!
Timepoint [6]
0
0
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8
Query!
Secondary outcome [7]
0
0
PFS Based on Radiology Assessments and Using RECIST 1.1 Criteria
Query!
Assessment method [7]
0
0
PFS in patients with PIK3CA mutant status and patients with PIK3CA non-mutant status as measured in ctDNA.
Query!
Timepoint [7]
0
0
Baseline, Up to approximatly 36 months
Query!
Secondary outcome [8]
0
0
Clinical Benefit Rate (CBR)
Query!
Assessment method [8]
0
0
Clinical benefit rate is defined as the proportion of patients with a best overall response of CR or PR or SD or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment.
Query!
Timepoint [8]
0
0
Up to approximatly 36 months
Query!
Secondary outcome [9]
0
0
Change in the Global Health Status/(QOL) Scale Score of the EORTC QLQ-C30
Query!
Assessment method [9]
0
0
Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized
Query!
Timepoint [9]
0
0
Baseline, Up to approximatly 36 months
Query!
Secondary outcome [10]
0
0
Summary Statistics of Fulvestrant and Alpelisib Plasma Concentrations
Query!
Assessment method [10]
0
0
Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples.
Query!
Timepoint [10]
0
0
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8
Query!
Secondary outcome [11]
0
0
PFS for Patients With PIK3CA Non-mutant Status
Query!
Assessment method [11]
0
0
PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort
Query!
Timepoint [11]
0
0
Up to approximatly 36 months
Query!
Secondary outcome [12]
0
0
OS for Patients With PIK3CA Non-mutant Status
Query!
Assessment method [12]
0
0
OS is defined as the time from date of randomization to date of death due to any cause.
Query!
Timepoint [12]
0
0
Up to approximatly 59 months
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
9/06/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
572
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Wahroonga
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Wooloongabba
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Elizabeth Vale
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2076 - Wahroonga
Query!
Recruitment postcode(s) [2]
0
0
4102 - Wooloongabba
Query!
Recruitment postcode(s) [3]
0
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [4]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Montana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oregon
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Dakota
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Buenos Aires
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Viedma
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
La Rioja
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Linz
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Vienna
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Antwerpen
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Brussel
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Oost Vlaanderen
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Bruxelles
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Libramont
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Ottignies
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Verviers
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
RN
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
RS
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
SP
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Sao Jose do Rio Preto
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Sao Paulo
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Plovdiv
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sofia
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Varna
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Alberta
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Ontario
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Quebec
Query!
Country [46]
0
0
Chile
Query!
State/province [46]
0
0
Araucania
Query!
Country [47]
0
0
Chile
Query!
State/province [47]
0
0
Santiago
Query!
Country [48]
0
0
Chile
Query!
State/province [48]
0
0
Vina del Mar
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Czech Republic
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Prague 8
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Bouches Du Rhone
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Angers 02
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Avignon
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Caen
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Clermont Ferrand
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Creteil
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
La Roche sur Yon cedex 9
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Le Chesnay
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Levallois-Perret
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Lyon Cedex 08
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Montpellier
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Nimes
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Rouen
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Saint-Herblain Cédex
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Toulouse
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Villejuif Cedex
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
North Rhine-westphalia
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Sachsen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Schleswig-Holstein
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Aschaffenburg
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Frankfurt
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Friedrichshafen
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Hannover
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Homburg
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Kiel
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Mainz
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Potsdam
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Rostock
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Ulm
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Velbert
Query!
Country [81]
0
0
Greece
Query!
State/province [81]
0
0
GR
Query!
Country [82]
0
0
Greece
Query!
State/province [82]
0
0
Athens
Query!
Country [83]
0
0
Hong Kong
Query!
State/province [83]
0
0
Hong Kong
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Budapest
Query!
Country [85]
0
0
Hungary
Query!
State/province [85]
0
0
Nyiregyhaza
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Szekszard
Query!
Country [87]
0
0
India
Query!
State/province [87]
0
0
Andhra Pradesh
Query!
Country [88]
0
0
India
Query!
State/province [88]
0
0
Maharashtra
Query!
Country [89]
0
0
India
Query!
State/province [89]
0
0
Mumbai
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Beer-Sheva
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Haifa
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Petach Tikva
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Ramat Gan
Query!
Country [94]
0
0
Israel
Query!
State/province [94]
0
0
Tel Aviv
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
AN
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
CH
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
FC
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
MI
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
PA
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
PD
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
PI
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
PN
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
PZ
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
RM
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
SS
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
SV
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
TO
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
VR
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Aichi
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Ehime
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Gunma
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Hokkaido
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Hyogo
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Kagoshima
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kanagawa
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Kumamoto
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Osaka
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Saitama
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Tokyo
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Gyeonggi Do
Query!
Country [121]
0
0
Korea, Republic of
Query!
State/province [121]
0
0
Korea
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Seoul
Query!
Country [123]
0
0
Lebanon
Query!
State/province [123]
0
0
Ashrafieh
Query!
Country [124]
0
0
Lebanon
Query!
State/province [124]
0
0
Beirut
Query!
Country [125]
0
0
Lebanon
Query!
State/province [125]
0
0
Saida
Query!
Country [126]
0
0
Mexico
Query!
State/province [126]
0
0
Monterrey
Query!
Country [127]
0
0
Mexico
Query!
State/province [127]
0
0
San Luis Potosi
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
CE
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Terneuzen
Query!
Country [130]
0
0
Peru
Query!
State/province [130]
0
0
Lima
Query!
Country [131]
0
0
Romania
Query!
State/province [131]
0
0
Cluj
Query!
Country [132]
0
0
Romania
Query!
State/province [132]
0
0
Dolj
Query!
Country [133]
0
0
Romania
Query!
State/province [133]
0
0
Iasi
Query!
Country [134]
0
0
Russian Federation
Query!
State/province [134]
0
0
Arkhangelsk
Query!
Country [135]
0
0
Russian Federation
Query!
State/province [135]
0
0
Ryazan
Query!
Country [136]
0
0
Russian Federation
Query!
State/province [136]
0
0
St Petersburg
Query!
Country [137]
0
0
Spain
Query!
State/province [137]
0
0
Andalucia
Query!
Country [138]
0
0
Spain
Query!
State/province [138]
0
0
Cadiz
Query!
Country [139]
0
0
Spain
Query!
State/province [139]
0
0
Cataluna
Query!
Country [140]
0
0
Spain
Query!
State/province [140]
0
0
Catalunya
Query!
Country [141]
0
0
Spain
Query!
State/province [141]
0
0
Comunidad Valenciana
Query!
Country [142]
0
0
Spain
Query!
State/province [142]
0
0
Extremadura
Query!
Country [143]
0
0
Spain
Query!
State/province [143]
0
0
Galicia
Query!
Country [144]
0
0
Spain
Query!
State/province [144]
0
0
Islas Baleares
Query!
Country [145]
0
0
Spain
Query!
State/province [145]
0
0
Madrid
Query!
Country [146]
0
0
Spain
Query!
State/province [146]
0
0
Murcia
Query!
Country [147]
0
0
Spain
Query!
State/province [147]
0
0
Santa Cruz De Tenerife
Query!
Country [148]
0
0
Sweden
Query!
State/province [148]
0
0
Gavle
Query!
Country [149]
0
0
Sweden
Query!
State/province [149]
0
0
Oerebro
Query!
Country [150]
0
0
Sweden
Query!
State/province [150]
0
0
Vasteras
Query!
Country [151]
0
0
Taiwan
Query!
State/province [151]
0
0
Taipei
Query!
Country [152]
0
0
Thailand
Query!
State/province [152]
0
0
THA
Query!
Country [153]
0
0
Thailand
Query!
State/province [153]
0
0
Bangkok
Query!
Country [154]
0
0
United Kingdom
Query!
State/province [154]
0
0
Devon
Query!
Country [155]
0
0
United Kingdom
Query!
State/province [155]
0
0
Leicester
Query!
Country [156]
0
0
United Kingdom
Query!
State/province [156]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02437318
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02437318
Download to PDF